Pfizer Inc. (PFE)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761369 - PFIZER INC | |||||||
| HYMPAVZI | MARSTACIMAB-HNCQ | INJECTABLE;SUBCUTANEOUS | 300MG | Prescription | |||
| BLA761345 - PFIZER INC | |||||||
| ELREXFIO | ELRANATAMAB | SOLUTION;INJECTION | 12MG | Prescription | |||
| BLA761184 - PFIZER IRELAND PHARMACEUTICALS | |||||||
| NGENLA | SOMATROGON-GHLA | INJECTABLE;INJECTION | 24MG | Prescription | |||
| NGENLA | SOMATROGON-GHLA | INJECTABLE;INJECTION | 60MG | Prescription | |||
| BLA761118 - PFIZER INC | |||||||
| ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 40MG/0.8ML | Prescription | |||
| ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 20MG/0.4ML | Prescription | |||
| ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 10MG/0.2ML | Prescription | |||
| BLA761103 - PFIZER INC | |||||||
| RUXIENCE | RITUXIMAB-PVVR | INJECTABLE;INJECTION | 100MG/10ML(10MG/ML) | Prescription | |||
| RUXIENCE | RITUXIMAB-PVVR | INJECTABLE;INJECTION | 500MG/50ML(10MG/ML) | Prescription | |||
| BLA761099 - PFIZER INC | |||||||
| ZIRABEV | BEVACIZUMAB-BVZR | INJECTABLE;INJECTION | 100MG/4ML | Prescription | |||
| ZIRABEV | BEVACIZUMAB-BVZR | INJECTABLE;INJECTION | 400MG/16ML | Prescription | |||
| BLA761081 - PFIZER INC | |||||||
| TRAZIMERA | TRASTUZUMAB-QYYP | INJECTABLE;INJECTION | 420MG | Prescription | |||
| BLA761072 - PFIZER INC | |||||||
| IXIFI | INFLIXIMAB-QBTX | INJECTABLE;INJECTION | 100MG/VIAL | Prescription | |||
| NDA217439 - PFIZER | |||||||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.1MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.25MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.35MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.5MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.75MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 1MG BASE | Prescription | |||
| NDA217188 - PFIZER | |||||||
| PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET;ORAL | 150MG;100MG | Prescription | |||
| PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET;ORAL | 300MG;100MG | Prescription | |||
| NDA216956 - PFIZER | |||||||
| VELSIPITY | ETRASIMOD ARGININE | TABLET;ORAL | EQ 2MG BASE | Prescription | |||
| NDA216386 - PFIZER | |||||||
| ZAVZPRET | ZAVEGEPANT HYDROCHLORIDE | SPRAY, METERED;NASAL | EQ 10MG BASE/SPRAY | Prescription | |||
| NDA215830 - PFIZER | |||||||
| LITFULO | RITLECITINIB TOSYLATE | CAPSULE;ORAL | EQ 50MG BASE | Prescription | |||
| NDA213871 - PFIZER | |||||||
| CIBINQO | ABROCITINIB | TABLET;ORAL | 100MG | Prescription | |||
| CIBINQO | ABROCITINIB | TABLET;ORAL | 200MG | Prescription | |||
| CIBINQO | ABROCITINIB | TABLET;ORAL | 50MG | Prescription | |||
| NDA213082 - PFIZER | |||||||
| XELJANZ | TOFACITINIB CITRATE | SOLUTION;ORAL | EQ 1MG BASE/ML | Prescription | |||
| NDA212728 - PFIZER | |||||||
| NURTEC ODT | RIMEGEPANT SULFATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 75MG BASE | Prescription | |||
| NDA212436 - PFIZER | |||||||
| IBRANCE | PALBOCICLIB | TABLET;ORAL | 125MG | Prescription | |||
| IBRANCE | PALBOCICLIB | TABLET;ORAL | 100MG | Prescription | |||
| IBRANCE | PALBOCICLIB | TABLET;ORAL | 75MG | Prescription | |||
| NDA212161 - FOLDRX PHARMS | |||||||
| VYNDAMAX | TAFAMIDIS | CAPSULE;ORAL | 61MG | Prescription | |||
| NDA211996 - FOLDRX PHARMS | |||||||
| VYNDAQEL | TAFAMIDIS MEGLUMINE | CAPSULE;ORAL | 20MG | Prescription | |||
| NDA211651 - PFIZER | |||||||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.25MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 1MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.5MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.35MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.75MG BASE | Prescription | |||
| TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE;ORAL | EQ 0.1MG BASE | Prescription | |||
| NDA211288 - PFIZER | |||||||
| VIZIMPRO | DACOMITINIB | TABLET;ORAL | 30MG | Prescription | |||
| VIZIMPRO | DACOMITINIB | TABLET;ORAL | 45MG | Prescription | |||
| VIZIMPRO | DACOMITINIB | TABLET;ORAL | 15MG | Prescription | |||
| NDA210868 - PFIZER | |||||||
| LORBRENA | LORLATINIB | TABLET;ORAL | 25MG | Prescription | |||
| LORBRENA | LORLATINIB | TABLET;ORAL | 100MG | Prescription | |||
| NDA210656 - PFIZER | |||||||
| DAURISMO | GLASDEGIB MALEATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| DAURISMO | GLASDEGIB MALEATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| NDA208246 - PFIZER | |||||||
| XELJANZ XR | TOFACITINIB CITRATE | TABLET, EXTENDED RELEASE;ORAL | EQ 11MG BASE | Prescription | |||
| XELJANZ XR | TOFACITINIB CITRATE | TABLET, EXTENDED RELEASE;ORAL | EQ 22MG BASE | Prescription | |||
| NDA207621 - PFIZER | |||||||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 1.2MG;10MG | Discontinued | |||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 2.4MG;20MG | Discontinued | |||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 3.6MG;30MG | Discontinued | |||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7.2MG;60MG | Discontinued | |||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 9.6MG;80MG | Discontinued | |||
| TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 4.8MG;40MG | Discontinued | |||
| NDA207103 - PFIZER | |||||||
| IBRANCE | PALBOCICLIB | CAPSULE;ORAL | 100MG | Prescription | |||
| IBRANCE | PALBOCICLIB | CAPSULE;ORAL | 125MG | Prescription | |||
| IBRANCE | PALBOCICLIB | CAPSULE;ORAL | 75MG | Prescription | |||
| ANDA205576 - INNOPHARMA | |||||||
| PROPOFOL | PROPOFOL | INJECTABLE;INJECTION | 10MG/ML | Prescription | |||
| ANDA203344 - PFIZER INC | |||||||
| ZOLEDRONIC ACID | ZOLEDRONIC ACID | INJECTABLE;INJECTION | 4MG/5ML | None (Tentative Approval) | |||
| NDA202356 - PFIZER LABS | |||||||
| DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 130MG/13ML (10MG/ML) | Discontinued | |||
| DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) | Discontinued | |||
| DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML (10MG/ML) | Discontinued | |||
| DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | Discontinued | |||
| NDA201370 - PFIZER | |||||||
| HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | Prescription | |||
| HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | Discontinued | |||
| HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | Prescription | |||
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | Prescription | |||
| ANDA085665 - ROERIG | |||||||
| SUSTAIRE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Discontinued | |||
| SUSTAIRE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | Discontinued | |||
| ANDA085635 - PFIZER | |||||||
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 50MG/ML | Discontinued | |||
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 100MG/ML | Prescription | |||
| DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 200MG/ML | Prescription | |||
| ANDA085470 - PFIZER | |||||||
| DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
| DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 3MG/ML | Discontinued | |||
| DEPO-ESTRADIOL | ESTRADIOL CYPIONATE | INJECTABLE;INJECTION | 5MG/ML | Prescription | |||
| ANDA083220 - PFIZER | |||||||
| OGEN 5 | ESTROPIPATE | TABLET;ORAL | 6MG | Prescription | |||
| OGEN 2.5 | ESTROPIPATE | TABLET;ORAL | 3MG | Discontinued | |||
| OGEN 1.25 | ESTROPIPATE | TABLET;ORAL | 1.5MG | Discontinued | |||
| OGEN .625 | ESTROPIPATE | TABLET;ORAL | 0.75MG | Discontinued | |||
| ANDA080258 - PARKE-DAVIS | |||||||
| ZARONTIN | ETHOSUXIMIDE | SYRUP;ORAL | 250MG/5ML | Prescription | |||
| ANDA063333 - PFIZER | |||||||
| CEFOBID | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| CEFOBID | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
| ANDA063165 - PFIZER | |||||||
| ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | Discontinued | |||
| ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | Discontinued | |||
| ANDA062901 - PFIZER | |||||||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | Discontinued | |||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | Discontinued | |||
| ANDA062803 - PFIZER | |||||||
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 150MG BASE/ML | Prescription | |||
| ANDA062644 - PFIZER | |||||||
| CLEOCIN | CLINDAMYCIN PALMITATE HYDROCHLORIDE | FOR SOLUTION;ORAL | EQ 75MG BASE/5ML | Prescription | |||
| ANDA062310 - KING PFIZER | |||||||
| HUMATIN | PAROMOMYCIN SULFATE | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
| ANDA062050 - PFIZER | |||||||
| PFIZERPEN-A | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
| PFIZERPEN-A | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
| ANDA062049 - PFIZER | |||||||
| PFIZERPEN-A | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
| PFIZERPEN-A | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
| ANDA061841 - PFIZER | |||||||
| TERRAMYCIN W/ POLYMYXIN | OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | OINTMENT;OTIC | EQ 5MG BASE/GM;10,000 UNITS/GM | Discontinued | |||
| ANDA061836 - PFIZER | |||||||
| PFIZERPEN VK | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 250MG BASE | Discontinued | |||
| PFIZERPEN VK | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 500MG BASE | Discontinued | |||
| ANDA061815 - PFIZER | |||||||
| PFIZERPEN VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
| PFIZERPEN VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
| ANDA061791 - PFIZER | |||||||
| PFIZER-E | ERYTHROMYCIN STEARATE | TABLET;ORAL | EQ 250MG BASE | Discontinued | |||
| PFIZER-E | ERYTHROMYCIN STEARATE | TABLET;ORAL | EQ 500MG BASE | Discontinued | |||
| ANDA061086 - PFIZER | |||||||
| VIOCIN SULFATE | VIOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | Discontinued | |||
| VIOCIN SULFATE | VIOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| ANDA061016 - PFIZER | |||||||
| TERRA-CORTRIL | HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE | SUSPENSION;OPHTHALMIC | 1.5%;EQ 5MG BASE/ML | Discontinued | |||
| ANDA061009 - PFIZER | |||||||
| TERRAMYCIN-POLYMYXIN | OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | TABLET;VAGINAL | EQ 100MG BASE;100,000 UNITS | Discontinued | |||
| ANDA060657 - PFIZER | |||||||
| PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 5,000,000 UNITS/VIAL | Prescription | |||
| PFIZERPEN | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 20,000,000 UNITS/VIAL | Prescription | |||
| ANDA060595 - PFIZER | |||||||
| TERRAMYCIN | OXYTETRACYCLINE CALCIUM | SYRUP;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
| ANDA060587 - PFIZER | |||||||
| PFIZERPEN G | PENICILLIN G POTASSIUM | FOR SOLUTION;ORAL | 400,000 UNITS/5ML | Discontinued | |||
| ANDA060586 - PFIZER | |||||||
| TERRAMYCIN | OXYTETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Discontinued | |||
| TERRAMYCIN | OXYTETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | Discontinued | |||
| ANDA060567 - PFIZER | |||||||
| TERRAMYCIN | LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE | INJECTABLE;INJECTION | 2%;50MG/ML | Discontinued | |||
| TERRAMYCIN | LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE | INJECTABLE;INJECTION | 2%;125MG/ML | Discontinued | |||
| ANDA060475 - PFIZER | |||||||
| NEOBIOTIC | NEOMYCIN SULFATE | TABLET;ORAL | EQ 350MG BASE | Discontinued | |||
| ANDA060286 - PFIZER | |||||||
| PFIZERPEN-AS | PENICILLIN G PROCAINE | INJECTABLE;INJECTION | 300,000 UNITS/ML | Discontinued | |||
| PFIZERPEN-AS | PENICILLIN G PROCAINE | INJECTABLE;INJECTION | 600,000 UNITS/ML | Discontinued | |||
| ANDA060285 - PFIZER | |||||||
| TETRACYN | PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/VIAL;100MG/VIAL | Discontinued | |||
| TETRACYN | PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/VIAL;250MG/VIAL | Discontinued | |||
| ANDA060111 - PFIZER | |||||||
| STREPTOMYCIN SULFATE | STREPTOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1GM BASE/2.5ML | Discontinued | |||
| ANDA060099 - PFIZER | |||||||
| PENICILLIN G PROCAINE | PENICILLIN G PROCAINE | INJECTABLE;INJECTION | 300,000 UNITS/VIAL | Discontinued | |||
| PENICILLIN G PROCAINE | PENICILLIN G PROCAINE | INJECTABLE;INJECTION | 1,500,000 UNITS/VIAL | Discontinued | |||
| ANDA060096 - PFIZER | |||||||
| TETRACYN | TETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 250MG/VIAL | Discontinued | |||
| TETRACYN | TETRACYCLINE HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/VIAL | Discontinued | |||
| ANDA060095 - PFIPHARMECS | |||||||
| TETRACYN | TETRACYCLINE HYDROCHLORIDE | SUSPENSION;ORAL | 125MG/5ML | Discontinued | |||
| ANDA060082 - PFIPHARMECS | |||||||
| TETRACYN | TETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | 500MG | Discontinued | |||
| TETRACYN | TETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | Discontinued | |||
| ANDA060076 - PFIZER | |||||||
| STREPTOMYCIN SULFATE | STREPTOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| STREPTOMYCIN SULFATE | STREPTOMYCIN SULFATE | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANDA060075 - PFIZER | |||||||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 250,000 UNITS | Discontinued | |||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 100,000 UNITS | Discontinued | |||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 200,000 UNITS | Discontinued | |||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 400,000 UNITS | Discontinued | |||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 800,000 UNITS | Discontinued | |||
| PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 50,000 UNITS | Discontinued | |||
| ANDA060074 - PFIZER | |||||||
| PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | INJECTABLE;INJECTION | 20,000,000 UNITS/VIAL | Discontinued | |||
| NDA050784 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | Prescription | |||
| NDA050778 - PFIZER INC | |||||||
| ELLENCE | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | Prescription | |||
| ELLENCE | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | Prescription | |||
| NDA050767 - PFIZER | |||||||
| CLEOCIN | CLINDAMYCIN PHOSPHATE | SUPPOSITORY;VAGINAL | 100MG | Prescription | |||
| NDA050762 - PFIZER | |||||||
| TROVAN/ZITHROMAX COMPLIANCE PAK | AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE | FOR SUSPENSION, TABLET;ORAL | EQ 1GM BASE,N/A;N/A,EQ 100MG BASE | Discontinued | |||
| NDA050734 - PFIZER | |||||||
| IDAMYCIN PFS | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | Prescription | |||
| NDA050733 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Prescription | |||
| NDA050730 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | TABLET;ORAL | EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050711 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | Prescription | |||
| NDA050710 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | Prescription | |||
| ZITHROMAX | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | Prescription | |||
| NDA050706 - PFIZER | |||||||
| MERREM | MEROPENEM | INJECTABLE;INJECTION | 500MG/VIAL | Prescription | |||
| MERREM | MEROPENEM | INJECTABLE;INJECTION | 1GM/VIAL | Prescription | |||
| NDA050693 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 1GM BASE/PACKET | Prescription | |||
| NDA050689 - PFIZER | |||||||
| MYCOBUTIN | RIFABUTIN | CAPSULE;ORAL | 150MG | Prescription | |||
| NDA050684 - WYETH PHARMS | |||||||
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | INJECTABLE;INJECTION | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050680 - PFIZER | |||||||
| CLEOCIN | CLINDAMYCIN PHOSPHATE | CREAM;VAGINAL | EQ 2% BASE | Prescription | |||
| CLEOCIN | CLINDAMYCIN PHOSPHATE | CREAM;VAGINAL | EQ 2% BASE | Discontinued | |||
| NDA050670 - PFIZER | |||||||
| ZITHROMAX | AZITHROMYCIN | CAPSULE;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050661 - PFIZER | |||||||
| IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | Discontinued | |||
| IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/VIAL | Discontinued | |||
| IDAMYCIN | IDARUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/VIAL | Discontinued | |||
| NDA050639 - PFIZER | |||||||
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 12MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 18MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050629 - PFIZER | |||||||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | Prescription | |||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/75ML | Prescription | |||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | Prescription | |||
| NDA050615 - PFIZER | |||||||
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | GEL;TOPICAL | EQ 1% BASE | Prescription | |||
| NDA050613 - PFIZER | |||||||
| CEFOBID IN PLASTIC CONTAINER | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML | Discontinued | |||
| CEFOBID IN PLASTIC CONTAINER | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML | Discontinued | |||
| NDA050608 - PFIZER | |||||||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | Prescription | |||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | Prescription | |||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL | Discontinued | |||
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | Prescription | |||
| NDA050600 - PFIZER | |||||||
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | LOTION;TOPICAL | EQ 1% BASE | Prescription | |||
| NDA050556 - PFIZER | |||||||
| SPECTROBID | BACAMPICILLIN HYDROCHLORIDE | FOR SUSPENSION;ORAL | 125MG/5ML | Discontinued | |||
| NDA050551 - PFIZER | |||||||
| CEFOBID | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| CEFOBID | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
| CEFOBID | CEFOPERAZONE SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
| NDA050537 - PFIZER | |||||||
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | SOLUTION;TOPICAL | EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CLEOCIN | CLINDAMYCIN PHOSPHATE | SWAB;TOPICAL | EQ 1% BASE | Discontinued | |||
| NDA050533 - PFIZER | |||||||
| VIBRA-TABS | DOXYCYCLINE HYCLATE | TABLET;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050520 - PFIZER | |||||||
| SPECTROBID | BACAMPICILLIN HYDROCHLORIDE | TABLET;ORAL | 800MG | Discontinued | |||
| SPECTROBID | BACAMPICILLIN HYDROCHLORIDE | TABLET;ORAL | 400MG | Discontinued | |||
| NDA050480 - PFIZER | |||||||
| VIBRAMYCIN | DOXYCYCLINE CALCIUM | SUSPENSION;ORAL | EQ 50MG BASE/5ML | Prescription | |||
| NDA050467 - PFIZER | |||||||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/VIAL | Discontinued | |||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/VIAL | Discontinued | |||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/VIAL | Discontinued | |||
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/VIAL | Discontinued | |||
| NDA050442 - PFIZER | |||||||
| VIBRAMYCIN | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VIBRAMYCIN | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050441 - PFIZER | |||||||
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 150MG BASE/ML | Prescription | |||
| NDA050435 - PFIZER | |||||||
| GEOCILLIN | CARBENICILLIN INDANYL SODIUM | TABLET;ORAL | EQ 382MG BASE | Discontinued | |||
| NDA050347 - PFIZER | |||||||
| TROBICIN | SPECTINOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
| TROBICIN | SPECTINOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL | Discontinued | |||
| NDA050336 - PFIZER | |||||||
| TAO | TROLEANDOMYCIN | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
| NDA050332 - PFIZER | |||||||
| TAO | TROLEANDOMYCIN | SUSPENSION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
| NDA050317 - PFIZER | |||||||
| LINCOCIN | LINCOMYCIN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 300MG BASE/ML | Prescription | |||
| NDA050306 - ROERIG | |||||||
| GEOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
| GEOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
| GEOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 30GM BASE/VIAL | Discontinued | |||
| GEOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | Discontinued | |||
| GEOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
| NDA050287 - PFIZER | |||||||
| TERRAMYCIN | OXYTETRACYCLINE | TABLET;ORAL | 250MG | Discontinued | |||
| NDA050286 - PFIZER | |||||||
| TERRAMYCIN | OXYTETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 125MG BASE | Discontinued | |||
| TERRAMYCIN | OXYTETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
| NDA050162 - PFIZER | |||||||
| CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | Prescription | |||
| CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | Prescription | |||
| CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | Prescription | |||
| NDA050109 - PFIZER | |||||||
| MITHRACIN | PLICAMYCIN | INJECTABLE;INJECTION | 2.5MG/VIAL | Discontinued | |||
| NDA050007 - PFIZER | |||||||
| VIBRAMYCIN | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VIBRAMYCIN | DOXYCYCLINE HYCLATE | CAPSULE;ORAL | EQ 100MG BASE | Prescription | |||
| NDA050006 - PFIZER | |||||||
| VIBRAMYCIN | DOXYCYCLINE | FOR SUSPENSION;ORAL | EQ 25MG BASE/5ML | Discontinued | |||
| BLA022458 - PFIZER | |||||||
| ELELYSO | TALIGLUCERASE ALFA | POWDER;INTRAVENOUS | 200 UNITS/VIAL | Prescription | |||
| NDA022247 - WYETH PHARMS | |||||||
| DUAVEE | BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED | TABLET;ORAL | EQ 20MG BASE;0.45MG | Prescription | |||
| NDA022030 - PFIZER | |||||||
| TOVIAZ | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 4MG | Prescription | |||
| TOVIAZ | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 8MG | Prescription | |||
| NDA022021 - KING PFIZER | |||||||
| ALTACE | RAMIPRIL | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALTACE | RAMIPRIL | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALTACE | RAMIPRIL | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALTACE | RAMIPRIL | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022020 - WYETH PHARMS | |||||||
| PROTONIX | PANTOPRAZOLE SODIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 40MG BASE | Prescription | |||
| NDA021948 - PFIZER | |||||||
| ERAXIS | ANIDULAFUNGIN | INJECTABLE; INJECTION | 50MG | Prescription | |||
| NDA021583 - PFIZER | |||||||
| DEPO-SUBQ PROVERA 104 | MEDROXYPROGESTERONE ACETATE | INJECTABLE;SUBCUTANEOUS | 104MG/0.65ML | Prescription | |||
| NDA021483 - PFIZER INC | |||||||
| GEODON | ZIPRASIDONE HYDROCHLORIDE | SUSPENSION;ORAL | EQ 10MG BASE/ML | Discontinued | |||
| NDA021466 - PFIZER | |||||||
| VFEND | VORICONAZOLE | Injectable; Iv (Infusion) | 200MG/VIAL | Prescription | |||
| VFEND | VORICONAZOLE | Tablet; Oral | 200MG | Prescription | |||
| VFEND | VORICONAZOLE | Tablet; Oral | 50MG | Prescription | |||
| NDA021464 - PFIZER | |||||||
| VFEND | VORICONAZOLE | Tablet; Oral | 200MG | Prescription | |||
| VFEND | VORICONAZOLE | Injectable; Injection | 200MG | Prescription | |||
| VFEND | VORICONAZOLE | Tablet; Oral | 50MG | Prescription | |||
| NDA021212 - PFIZER | |||||||
| CAVERJECT IMPULSE | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | Prescription | |||
| CAVERJECT IMPULSE | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | Prescription | |||
| NDA021132 - PFIZER | |||||||
| ZYVOX | LINEZOLID | FOR SUSPENSION;ORAL | 100MG/5ML | Prescription | |||
| NDA021131 - PFIZER | |||||||
| ZYVOX | LINEZOLID | SOLUTION;INTRAVENOUS | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZYVOX | LINEZOLID | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | Prescription | |||
| ZYVOX | LINEZOLID | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | Prescription | |||
| NDA021130 - PFIZER | |||||||
| ZYVOX | LINEZOLID | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ZYVOX | LINEZOLID | TABLET;ORAL | 600MG | Prescription | |||
| NDA020988 - WYETH PHARMS | |||||||
| PROTONIX IV | PANTOPRAZOLE SODIUM | INJECTABLE;INTRAVENOUS | EQ 40MG BASE/VIAL | Prescription | |||
| NDA020987 - WYETH PHARMS | |||||||
| PROTONIX | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 40MG BASE | Prescription | |||
| PROTONIX | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | Prescription | |||
| NDA020931 - PFIZER | |||||||
| TIKOSYN | DOFETILIDE | CAPSULE;ORAL | 0.125MG | Prescription | |||
| TIKOSYN | DOFETILIDE | CAPSULE;ORAL | 0.25MG | Prescription | |||
| TIKOSYN | DOFETILIDE | CAPSULE;ORAL | 0.5MG | Prescription | |||
| NDA020868 - PFIZER | |||||||
| FLAGYL ER | METRONIDAZOLE | TABLET, EXTENDED RELEASE;ORAL | 750MG | Discontinued | |||
| NDA020859 - PFIZER | |||||||
| SONATA | ZALEPLON | CAPSULE;ORAL | 5MG | Prescription | |||
| SONATA | ZALEPLON | CAPSULE;ORAL | 10MG | Prescription | |||
| NDA020776 - PFIZER | |||||||
| DAYPRO ALTA | OXAPROZIN POTASSIUM | TABLET;ORAL | 600MG | Discontinued | |||
| NDA020760 - PFIZER | |||||||
| TROVAN PRESERVATIVE FREE | ALATROFLOXACIN MESYLATE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | Discontinued | |||
| TROVAN PRESERVATIVE FREE | ALATROFLOXACIN MESYLATE | INJECTABLE;INJECTION | EQ 300MG BASE/VIAL | Discontinued | |||
| NDA020759 - PFIZER | |||||||
| TROVAN | TROVAFLOXACIN MESYLATE | TABLET;ORAL | EQ 200MG BASE | Discontinued | |||
| TROVAN | TROVAFLOXACIN MESYLATE | TABLET;ORAL | EQ 100MG BASE | Discontinued | |||
| NDA020755 - PFIZER | |||||||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.005MG/ML | Discontinued | |||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/ML | Discontinued | |||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/ML | Discontinued | |||
| NDA020753 - PFIZER | |||||||
| AROMASIN | EXEMESTANE | TABLET;ORAL | 25MG | Prescription | |||
| NDA020720 - PFIZER PHARMS | |||||||
| REZULIN | TROGLITAZONE | TABLET;ORAL | 400MG | Discontinued | |||
| REZULIN | TROGLITAZONE | TABLET;ORAL | 300MG | Discontinued | |||
| REZULIN | TROGLITAZONE | TABLET;ORAL | 200MG | Discontinued | |||
| NDA020714 - PFIZER | |||||||
| NICOTROL | NICOTINE | INHALANT;ORAL | 4MG/CARTRIDGE | Prescription | |||
| NDA020682 - PFIZER | |||||||
| GLYSET | MIGLITOL | TABLET;ORAL | 50MG | Prescription | |||
| GLYSET | MIGLITOL | TABLET;ORAL | 25MG | Prescription | |||
| GLYSET | MIGLITOL | TABLET;ORAL | 100MG | Prescription | |||
| NDA020664 - PFIZER | |||||||
| DOSTINEX | CABERGOLINE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020607 - PFIZER | |||||||
| ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | TABLET, DELAYED RELEASE;ORAL | 50MG;0.2MG | Prescription | |||
| ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | TABLET, DELAYED RELEASE;ORAL | 75MG;0.2MG | Prescription | |||
| NDA020571 - PFIZER INC | |||||||
| CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | Prescription | |||
| CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | Prescription | |||
| CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 300MG/15ML (20MG/ML) | Prescription | |||
| NDA020552 - PFIZER | |||||||
| COVERA-HS | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG | Discontinued | |||
| COVERA-HS | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | Discontinued | |||
| NDA020527 - WYETH PHARMS | |||||||
| PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | TABLET;ORAL-28 | 0.625MG;2.5MG | Prescription | |||
| PREMPHASE 14/14 | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | TABLET;ORAL-28 | 0.625MG,0.625MG;N/A,5MG | Prescription | |||
| PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | TABLET;ORAL-28 | 0.625MG;5MG | Prescription | |||
| PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | TABLET;ORAL-28 | 0.3MG;1.5MG | Prescription | |||
| PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | TABLET;ORAL-28 | 0.45MG;1.5MG | Prescription | |||
| NDA020491 - PFIZER | |||||||
| CORVERT | IBUTILIDE FUMARATE | INJECTABLE;INJECTION | 0.1MG/ML | Prescription | |||
| NDA020472 - PFIZER | |||||||
| ESTRING | ESTRADIOL | INSERT, EXTENDED RELEASE;VAGINAL | 0.0075MG/24HR | Prescription | |||
| NDA020385 - PFIZER INC | |||||||
| NICOTROL | NICOTINE | SPRAY, METERED;NASAL | 0.5MG/SPRAY | Prescription | |||
| NDA020379 - PFIZER | |||||||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | Prescription | |||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | Prescription | |||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.005MG/VIAL | Discontinued | |||
| CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.04MG/VIAL | Prescription | |||
| NDA020334 - PFIZER | |||||||
| FLAGYL | METRONIDAZOLE | CAPSULE;ORAL | 375MG | Prescription | |||
| NDA020329 - PFIZER | |||||||
| GLUCOTROL XL | GLIPIZIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | Prescription | |||
| GLUCOTROL XL | GLIPIZIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | Prescription | |||
| GLUCOTROL XL | GLIPIZIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | Prescription | |||
| NDA020287 - PFIZER | |||||||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 15,000IU/0.6ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 2,500IU/0.2ML (12,500IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/0.4ML (25,000IU/ML) | Discontinued | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 5,000IU/0.2ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/ML (10,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 7,500IU/0.3ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 95,000IU/3.8ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 12,500IU/0.5ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 18,000IU/0.72ML (25,000IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/4ML (2,500IU/ML) | Prescription | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 95,000IU/9.5ML (10,000IU/ML) | Discontinued | |||
| FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;INJECTION | 7,500 IU/0.75ML | Discontinued | |||
| NDA020246 - PFIZER | |||||||
| DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 150MG/ML | Prescription | |||
| NDA020222 - PFIZER | |||||||
| COLESTID | COLESTIPOL HYDROCHLORIDE | TABLET;ORAL | 1GM | Prescription | |||
| NDA020216 - WYETH PHARMS | |||||||
| PREMARIN | ESTROGENS, CONJUGATED | CREAM;TOPICAL, VAGINAL | 0.625MG/GM | Prescription | |||
| NDA020212 - PFIZER | |||||||
| ZINECARD | DEXRAZOXANE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | Discontinued | |||
| ZINECARD | DEXRAZOXANE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Discontinued | |||
| NDA020125 - PFIZER PHARMS | |||||||
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACCURETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020090 - PFIZER | |||||||
| DIFLUCAN | FLUCONAZOLE | FOR SUSPENSION;ORAL | 200MG/5ML | Prescription | |||
| DIFLUCAN | FLUCONAZOLE | FOR SUSPENSION;ORAL | 50MG/5ML | Prescription | |||
| NDA020051 - PFIZER | |||||||
| GLYNASE | GLYBURIDE | TABLET;ORAL | 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GLYNASE | GLYBURIDE | TABLET;ORAL | 3MG | Prescription | |||
| GLYNASE | GLYBURIDE | TABLET;ORAL | 1.5MG | Prescription | |||
| GLYNASE | GLYBURIDE | TABLET;ORAL | 6MG | Prescription | |||
| NDA019950 - PFIZER | |||||||
| DIFLUCAN IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | Discontinued | |||
| DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | Discontinued | |||
| DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | Discontinued | |||
| DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | Discontinued | |||
| DIFLUCAN IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | Discontinued | |||
| DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | Discontinued | |||
| NDA019949 - PFIZER | |||||||
| DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 200MG | Prescription | |||
| DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 150MG | Prescription | |||
| DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 50MG | Prescription | |||
| DIFLUCAN | FLUCONAZOLE | TABLET;ORAL | 100MG | Prescription | |||
| NDA019886 - PFIZER | |||||||
| SYNAREL | NAFARELIN ACETATE | SPRAY, METERED;NASAL | EQ 0.2MG BASE/SPRAY | Prescription | |||
| NDA019885 - PFIZER PHARMS | |||||||
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ACCUPRIL | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019775 - PFIZER | |||||||
| MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | Discontinued | |||
| MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | Discontinued | |||
| NDA019684 - PFIZER | |||||||
| PROCARDIA XL | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | Prescription | |||
| PROCARDIA XL | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Prescription | |||
| PROCARDIA XL | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Prescription | |||
| NDA019617 - PFIZER | |||||||
| PREPIDIL | DINOPROSTONE | GEL;ENDOCERVICAL | 0.5MG/3GM | Prescription | |||
| NDA019440 - PFIZER | |||||||
| UNISOM | DOXYLAMINE SUCCINATE | CAPSULE;ORAL | 25MG | Discontinued | |||
| NDA019281 - PFIZER | |||||||
| CYKLOKAPRON | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | Prescription | |||
| NDA019268 - PFIZER | |||||||
| CYTOTEC | MISOPROSTOL | TABLET;ORAL | 0.1MG | Prescription | |||
| CYTOTEC | MISOPROSTOL | TABLET;ORAL | 0.2MG | Prescription | |||
| NDA019260 - PFIZER | |||||||
| PSORCON | DIFLORASONE DIACETATE | OINTMENT;TOPICAL | 0.05% | Discontinued | |||
| NDA019259 - PFIZER | |||||||
| FLORONE E | DIFLORASONE DIACETATE | CREAM;TOPICAL | 0.05% | Discontinued | |||
| NDA019192 - WYETH PHARMS | |||||||
| TRIPHASIL-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019152 - PFIZER | |||||||
| CALAN SR | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CALAN SR | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CALAN SR | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018972 - WYETH PHARMS | |||||||
| CORDARONE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018926 - PFIZER | |||||||
| NORQUEST FE | ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;75MG;1MG | Discontinued | |||
| NDA018841 - PFIZER | |||||||
| DAYPRO | OXAPROZIN | TABLET;ORAL | 600MG | Prescription | |||
| NDA018817 - PFIZER | |||||||
| CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018682 - PFIZER | |||||||
| TZ-3 | TIOCONAZOLE | CREAM;TOPICAL | 1% | Discontinued | |||
| NDA018655 - PFIZER | |||||||
| NORPACE CR | DISOPYRAMIDE PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 150MG BASE | Prescription | |||
| NORPACE CR | DISOPYRAMIDE PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 100MG BASE | Prescription | |||
| NDA018484 - PFIZER | |||||||
| PROSTIN VR PEDIATRIC | ALPROSTADIL | INJECTABLE;INJECTION | 0.5MG/ML | Prescription | |||
| NDA018482 - PFIZER | |||||||
| PROCARDIA | NIFEDIPINE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROCARDIA | NIFEDIPINE | CAPSULE;ORAL | 10MG | Prescription | |||
| NDA018422 - PFIZER PHARMS | |||||||
| LOPID | GEMFIBROZIL | CAPSULE;ORAL | 200MG | Discontinued | |||
| LOPID | GEMFIBROZIL | CAPSULE;ORAL | 300MG | Discontinued | |||
| LOPID | GEMFIBROZIL | TABLET;ORAL | 600MG | Prescription | |||
| NDA018353 - PFIZER | |||||||
| FLAGYL I.V. | METRONIDAZOLE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FLAGYL I.V. RTU IN PLASTIC CONTAINER | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | Discontinued | |||
| NDA018154 - PFIZER | |||||||
| LONITEN | MINOXIDIL | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| LONITEN | MINOXIDIL | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018147 - PFIZER | |||||||
| FELDENE | PIROXICAM | CAPSULE;ORAL | 10MG | Prescription | |||
| FELDENE | PIROXICAM | CAPSULE;ORAL | 20MG | Prescription | |||
| NDA018069 - PFIZER | |||||||
| VANSIL | OXAMNIQUINE | CAPSULE;ORAL | 250MG | Discontinued | |||
| NDA017994 - PFIZER | |||||||
| PSORCON E | DIFLORASONE DIACETATE | OINTMENT;TOPICAL | 0.05% | Discontinued | |||
| NDA017989 - PFIZER | |||||||
| HEMABATE | CARBOPROST TROMETHAMINE | INJECTABLE;INJECTION | EQ 0.25MG BASE/ML | Prescription | |||
| NDA017986 - PFIZER | |||||||
| MINIZIDE | POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.5MG;EQ 1MG BASE | Discontinued | |||
| MINIZIDE | POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.5MG;EQ 2MG BASE | Discontinued | |||
| MINIZIDE | POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.5MG;EQ 5MG BASE | Discontinued | |||
| NDA017892 - PFIZER | |||||||
| HALCION | TRIAZOLAM | TABLET;ORAL | 0.5MG | Discontinued | |||
| HALCION | TRIAZOLAM | TABLET;ORAL | 0.125MG | Prescription | |||
| HALCION | TRIAZOLAM | TABLET;ORAL | 0.25MG | Prescription | |||
| NDA017810 - PFIZER | |||||||
| PROSTIN E2 | DINOPROSTONE | SUPPOSITORY;VAGINAL | 20MG | Discontinued | |||
| NDA017802 - WYETH PHARMS | |||||||
| LO/OVRAL-28 | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017783 - PFIZER | |||||||
| GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017741 - PFIZER | |||||||
| FLORONE | DIFLORASONE DIACETATE | CREAM;TOPICAL | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017563 - PFIZER | |||||||
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | GRANULE;ORAL | 5GM/PACKET | Discontinued | |||
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | GRANULE;ORAL | 5GM/SCOOPFUL | Discontinued | |||
| COLESTID | COLESTIPOL HYDROCHLORIDE | GRANULE;ORAL | 5GM/SCOOPFUL | Prescription | |||
| COLESTID | COLESTIPOL HYDROCHLORIDE | GRANULE;ORAL | 5GM/PACKET | Prescription | |||
| NDA017516 - PFIZER | |||||||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017498 - PFIZER | |||||||
| MICRONASE | GLYBURIDE | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MICRONASE | GLYBURIDE | TABLET;ORAL | 2.5MG | Discontinued | |||
| MICRONASE | GLYBURIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017447 - PFIZER | |||||||
| NORPACE | DISOPYRAMIDE PHOSPHATE | CAPSULE;ORAL | EQ 100MG BASE | Prescription | |||
| NORPACE | DISOPYRAMIDE PHOSPHATE | CAPSULE;ORAL | EQ 150MG BASE | Prescription | |||
| NDA017442 - PFIZER | |||||||
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE | Prescription | |||
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE | Prescription | |||
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | Prescription | |||
| NDA016904 - PFIZER | |||||||
| NAVANE | THIOTHIXENE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Discontinued | |||
| NAVANE | THIOTHIXENE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10MG BASE/VIAL | Discontinued | |||
| NDA016834 - PFIZER | |||||||
| LITHIUM CARBONATE | LITHIUM CARBONATE | TABLET;ORAL | 300MG | Discontinued | |||
| NDA016820 - PFIZER | |||||||
| EMETE-CON | BENZQUINAMIDE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | Discontinued | |||
| NDA016818 - ROERIG | |||||||
| EMETE-CON | BENZQUINAMIDE HYDROCHLORIDE | SUPPOSITORY;RECTAL | EQ 100MG BASE | Discontinued | |||
| NDA016806 - WYETH PHARMS | |||||||
| OVRAL-28 | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.05MG;0.5MG | Discontinued | |||
| NDA016798 - PFIZER | |||||||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016758 - PFIZER | |||||||
| NAVANE | THIOTHIXENE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 5MG BASE/ML | Discontinued | |||
| NDA016672 - WYETH PHARMS | |||||||
| OVRAL | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-21 | 0.05MG;0.5MG | Discontinued | |||
| NDA016584 - PFIZER | |||||||
| NAVANE | THIOTHIXENE | CAPSULE;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NAVANE | THIOTHIXENE | CAPSULE;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NAVANE | THIOTHIXENE | CAPSULE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NAVANE | THIOTHIXENE | CAPSULE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NAVANE | THIOTHIXENE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016418 - WYETH PHARMS | |||||||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INDERAL | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA013636 - PFIZER | |||||||
| RENESE-R | POLYTHIAZIDE; RESERPINE | TABLET;ORAL | 2MG;0.25MG | Discontinued | |||
| NDA013026 - WYETH PHARMS | |||||||
| TRECATOR | ETHIONAMIDE | TABLET;ORAL | 250MG | Prescription | |||
| NDA012845 - PFIZER | |||||||
| RENESE | POLYTHIAZIDE | TABLET;ORAL | 2MG | Discontinued | |||
| RENESE | POLYTHIAZIDE | TABLET;ORAL | 1MG | Discontinued | |||
| RENESE | POLYTHIAZIDE | TABLET;ORAL | 4MG | Discontinued | |||
| NDA012623 - PFIZER | |||||||
| FLAGYL | METRONIDAZOLE | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| FLAGYL | METRONIDAZOLE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012616 - PFIZER | |||||||
| ALDACTAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | TABLET;ORAL | 25MG;25MG | Prescription | |||
| ALDACTAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | TABLET;ORAL | 50MG;50MG | Discontinued | |||
| NDA012541 - PFIZER | |||||||
| DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 400MG/ML | Discontinued | |||
| NDA012462 - PFIZER | |||||||
| LOMOTIL | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | TABLET;ORAL | 0.025MG;2.5MG | Prescription | |||
| NDA012427 - PFIZER | |||||||
| DIDREX | BENZPHETAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DIDREX | BENZPHETAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012151 - PFIZER | |||||||
| ALDACTONE | SPIRONOLACTONE | TABLET;ORAL | 50MG | Prescription | |||
| ALDACTONE | SPIRONOLACTONE | TABLET;ORAL | 100MG | Prescription | |||
| ALDACTONE | SPIRONOLACTONE | TABLET;ORAL | 25MG | Prescription | |||
| NDA012128 - PFIZER | |||||||
| FOVANE | BENZTHIAZIDE | TABLET;ORAL | 50MG | Discontinued | |||
| URESE | BENZTHIAZIDE | TABLET;ORAL | 25MG | Discontinued | |||
| NDA011839 - PFIZER | |||||||
| PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 2.5MG | Prescription | |||
| PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 5MG | Prescription | |||
| PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 10MG | Prescription | |||
| NDA011795 - PFIZER | |||||||
| VISTARIL | HYDROXYZINE PAMOATE | SUSPENSION;ORAL | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011757 - PFIZER | |||||||
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 40MG/ML | Prescription | |||
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 20MG/ML | Prescription | |||
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | INJECTABLE;INJECTION | 80MG/ML | Prescription | |||
| NDA011641 - PFIZER | |||||||
| DIABINESE | CHLORPROPAMIDE | TABLET;ORAL | 100MG | Discontinued | |||
| DIABINESE | CHLORPROPAMIDE | TABLET;ORAL | 250MG | Discontinued | |||
| NDA011612 - PFIZER | |||||||
| DARICON | OXYPHENCYCLIMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA011459 - PFIZER | |||||||
| VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 25MG HYDROCHLORIDE | Prescription | |||
| VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 50MG HYDROCHLORIDE | Prescription | |||
| VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011446 - PFIZER | |||||||
| STERANE | PREDNISOLONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA011210 - PFIZER | |||||||
| TESSALON | BENZONATATE | CAPSULE;ORAL | 100MG | Prescription | |||
| TESSALON | BENZONATATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011153 - PFIZER | |||||||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 4MG | Prescription | |||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 2MG | Prescription | |||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 16MG | Prescription | |||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 8MG | Prescription | |||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 24MG | Discontinued | |||
| MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 32MG | Prescription | |||
| NDA011111 - PFIZER | |||||||
| VISTARIL | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| VISTARIL | HYDROXYZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA010686 - PFIZER | |||||||
| MODERIL | RESCINNAMINE | TABLET;ORAL | 0.5MG | Discontinued | |||
| MODERIL | RESCINNAMINE | TABLET;ORAL | 0.25MG | Discontinued | |||
| NDA010554 - PFIZER | |||||||
| MAGNACORT | HYDROCORTAMATE HYDROCHLORIDE | OINTMENT;TOPICAL | 0.5% | Discontinued | |||
| NDA010485 - ROERIG | |||||||
| ATARAX | HYDROXYZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA010402 - WYETH PHARMS | |||||||
| PREMARIN | ESTROGENS, CONJUGATED | INJECTABLE;INJECTION | 25MG/VIAL | Prescription | |||
| NDA010392 - PFIZER | |||||||
| ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ATARAX | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA009996 - PFIZER | |||||||
| STERANE | PREDNISOLONE | TABLET;ORAL | 5MG | Discontinued | |||
| NDA009796 - PFIPHARMECS | |||||||
| CORTRIL | HYDROCORTISONE | TABLET;VAGINAL | 10MG | Discontinued | |||
| NDA009176 - PFIZER GLOBAL | |||||||
| CORTRIL | HYDROCORTISONE | OINTMENT;TOPICAL | 1% | Discontinued | |||
| CORTRIL | HYDROCORTISONE | OINTMENT;TOPICAL | 2.5% | Discontinued | |||
| NDA009164 - PFIZER | |||||||
| CORTRIL | HYDROCORTISONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA009127 - PFIZER | |||||||
| CORTRIL | HYDROCORTISONE | TABLET;ORAL | 20MG | Discontinued | |||
| CORTRIL | HYDROCORTISONE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA007073 - PFIZER | |||||||
| AZULFIDINE EN-TABS | SULFASALAZINE | TABLET, DELAYED RELEASE;ORAL | 500MG | Prescription | |||
| AZULFIDINE | SULFASALAZINE | TABLET;ORAL | 500MG | Prescription | |||
| NDA004782 - WYETH PHARMS | |||||||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 1.25MG | Prescription | |||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 2.5MG | Discontinued | |||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 0.3MG | Prescription | |||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 0.625MG | Prescription | |||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 0.9MG | Prescription | |||
| PREMARIN | ESTROGENS, CONJUGATED | TABLET;ORAL | 0.45MG | Prescription | |||