AbbVie Inc. (ABBV)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
Application | Product Name | Active Ingredient | Form | Strength | Status | ||
---|---|---|---|---|---|---|---|
BLA761262 - ABBVIE INC | |||||||
SKYRIZI | RISANKIZUMAB-RZAA | INJECTABLE;INTRAVENOUS | 600MG/VIAL | Prescription | |||
BLA761105 - ABBVIE INC | |||||||
SKYRIZI | RISANKIZUMAB-RZAA | INJECTABLE;INJECTION | 75MG/0.83ML | Prescription | |||
SKYRIZI | RISANKIZUMAB-RZAA | INJECTABLE;INJECTION | 150MG/ML | Prescription | |||
NDA218347 - ABBVIE | |||||||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 15MG | Prescription | |||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 30MG | Prescription | |||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 45MG | Prescription | |||
RINVOQ LQ | UPADACITINIB | SOLUTION;ORAL | 1MG/ML | Prescription | |||
NDA216962 - ABBVIE | |||||||
VYALEV | FOSCARBIDOPA; FOSLEVODOPA | SOLUTION;SUBCUTANEOUS | 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) | Prescription | |||
NDA215206 - ABBVIE | |||||||
QULIPTA | ATOGEPANT | TABLET;ORAL | 60MG | Prescription | |||
QULIPTA | ATOGEPANT | TABLET;ORAL | 10MG | Prescription | |||
QULIPTA | ATOGEPANT | TABLET;ORAL | 30MG | Prescription | |||
NDA215110 - ABBVIE | |||||||
MAVYRET | GLECAPREVIR; PIBRENTASVIR | PELLETS;ORAL | 50MG;20MG/PACKET | Prescription | |||
NDA214660 - ABBVIE INC | |||||||
NDA214028 - ABBVIE | |||||||
VUITY | PILOCARPINE HYDROCHLORIDE | SOLUTION;OPHTHALMIC | 1.25% | Prescription | |||
NDA213388 - ABBVIE | |||||||
ORIAHNN (COPACKAGED) | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM | CAPSULE;ORAL | EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | Prescription | |||
NDA211911 - ABBVIE | |||||||
DURYSTA | BIMATOPROST | IMPLANT;OPHTHALMIC | 10MCG | Prescription | |||
NDA211765 - ABBVIE | |||||||
UBRELVY | UBROGEPANT | TABLET;ORAL | 50MG | Prescription | |||
UBRELVY | UBROGEPANT | TABLET;ORAL | 100MG | Prescription | |||
NDA211675 - ABBVIE | |||||||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 45MG | Prescription | |||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 30MG | Prescription | |||
RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 15MG | Prescription | |||
NDA210450 - ABBVIE | |||||||
ORILISSA | ELAGOLIX SODIUM | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
ORILISSA | ELAGOLIX SODIUM | TABLET;ORAL | EQ 150MG BASE | Prescription | |||
NDA209512 - ABBVIE | |||||||
NORVIR | RITONAVIR | POWDER;ORAL | 100MG/PACKET | Prescription | |||
NDA209394 - ABBVIE | |||||||
MAVYRET | GLECAPREVIR; PIBRENTASVIR | TABLET;ORAL | 100MG;40MG | Prescription | |||
NDA208624 - ABBVIE | |||||||
VIEKIRA XR | DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA208573 - ABBVIE | |||||||
VENCLEXTA | VENETOCLAX | TABLET;ORAL | 10MG | Prescription | |||
VENCLEXTA | VENETOCLAX | TABLET;ORAL | 100MG | Prescription | |||
VENCLEXTA | VENETOCLAX | TABLET;ORAL | 50MG | Prescription | |||
NDA207931 - ABBVIE | |||||||
TECHNIVIE | OMBITASVIR; PARITAPREVIR; RITONAVIR | TABLET;ORAL | 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA206940 - ABBVIE | |||||||
VIBERZI | ELUXADOLINE | TABLET;ORAL | 75MG | Prescription | |||
VIBERZI | ELUXADOLINE | TABLET;ORAL | 100MG | Prescription | |||
NDA206619 - ABBVIE | |||||||
VIEKIRA PAK (COPACKAGED) | DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR | TABLET;ORAL | EQ 250MG BASE;12.5MG, 75MG, 50MG | Discontinued | |||
NDA206494 - ABBVIE | |||||||
AVYCAZ | AVIBACTAM SODIUM; CEFTAZIDIME | POWDER;INTRAVENOUS | EQ 0.5GM BASE;2GM/VIAL | Prescription | |||
NDA206439 - ALLERGAN | |||||||
NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;14MG | Prescription | |||
NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;28MG | Prescription | |||
NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;7MG | Prescription | |||
NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;21MG | Prescription | |||
NDA206333 - ABBVIE | |||||||
KYBELLA | DEOXYCHOLIC ACID | SOLUTION;SUBCUTANEOUS | 20MG/2ML (10MG/ML) | Prescription | |||
NDA206302 - ABBVIE | |||||||
BYVALSON | NEBIVOLOL HYDROCHLORIDE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;80MG | Discontinued | |||
NDA204412 - ABBVIE | |||||||
DELZICOL | MESALAMINE | CAPSULE, DELAYED RELEASE;ORAL | 400MG | Prescription | |||
NDA204370 - ABBVIE | |||||||
VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 1.5MG BASE | Prescription | |||
VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4.5MG BASE | Prescription | |||
VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | Prescription | |||
VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 3MG BASE | Prescription | |||
NDA204168 - ABBVIE | |||||||
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 40MG BASE | Prescription | |||
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 120MG BASE | Prescription | |||
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 20MG BASE | Prescription | |||
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 80MG BASE | Prescription | |||
NDA203952 - ABBVIE | |||||||
DUOPA | CARBIDOPA; LEVODOPA | SUSPENSION;ENTERAL | 4.63MG/ML;20MG/ML | Prescription | |||
NDA203696 - ABBVIE ENDOCRINE | |||||||
LUPANETA PACK | LEUPROLIDE ACETATE; NORETHINDRONE ACETATE | INJECTABLE, TABLET;INTRAMUSCULAR, ORAL | 3.75MG/VIAL,N/A;N/A,5MG | Discontinued | |||
LUPANETA PACK | LEUPROLIDE ACETATE; NORETHINDRONE ACETATE | INJECTABLE, TABLET;INTRAMUSCULAR, ORAL | 11.25MG/VIAL,N/A;N/A,5MG | Discontinued | |||
NDA202811 - ABBVIE | |||||||
LINZESS | LINACLOTIDE | CAPSULE;ORAL | 290MCG | Prescription | |||
LINZESS | LINACLOTIDE | CAPSULE;ORAL | 145MCG | Prescription | |||
LINZESS | LINACLOTIDE | CAPSULE;ORAL | 72MCG | Prescription | |||
NDA202211 - ABBVIE | |||||||
OXYTROL FOR WOMEN | OXYBUTYNIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 3.9MG/24HR | Over-the-counter | |||
NDA200327 - ABBVIE | |||||||
TEFLARO | CEFTAROLINE FOSAMIL | POWDER;INTRAVENOUS | 600MG/VIAL | Prescription | |||
TEFLARO | CEFTAROLINE FOSAMIL | POWDER;INTRAVENOUS | 400MG/VIAL | Prescription | |||
BLA125057 - ABBVIE INC | |||||||
HUMIRA | ADALIMUMAB | VIAL | 40MG/0.8ML | Prescription | |||
HUMIRA | ADALIMUMAB | SYRINGE | 40MG/0.8ML | Prescription | |||
ANDA089736 - ABBVIE | |||||||
VICODIN ES | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 750MG;7.5MG | Discontinued | |||
ANDA088058 - ABBVIE | |||||||
VICODIN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 500MG;5MG | Discontinued | |||
ANDA087853 - ABBVIE | |||||||
ATROPINE AND DEMEROL | ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML;50MG/ML | Discontinued | |||
ANDA087848 - ABBVIE | |||||||
ATROPINE AND DEMEROL | ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML;100MG/ML | Discontinued | |||
ANDA087847 - ABBVIE | |||||||
ATROPINE AND DEMEROL | ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML;75MG/ML | Discontinued | |||
ANDA075729 - ABBVIE | |||||||
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER | FAMOTIDINE | INJECTABLE;INJECTION | 0.4MG/ML | Discontinued | |||
ANDA075114 - ABBVIE | |||||||
ACYCLOVIR | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 50MG BASE/ML | Discontinued | |||
ANDA074638 - ABBVIE | |||||||
IOPAMIDOL-300 | IOPAMIDOL | INJECTABLE;INJECTION | 61% | Discontinued | |||
ANDA071295 - ABBVIE | |||||||
ATROPINE | ATROPINE | SOLUTION;INTRAMUSCULAR | EQ 2MG SULFATE/0.7ML | Discontinued | |||
ANDA065025 - ABBVIE | |||||||
CYCLOSPORINE | CYCLOSPORINE | SOLUTION;ORAL | 100MG/ML | Prescription | |||
ANDA065003 - ABBVIE | |||||||
GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 50MG | Discontinued | |||
GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 100MG | Prescription | |||
GENGRAF | CYCLOSPORINE | CAPSULE;ORAL | 25MG | Prescription | |||
NDA050790 - ABBVIE | |||||||
RESTASIS MULTIDOSE | CYCLOSPORINE | EMULSION;OPHTHALMIC | 0.05% | Prescription | |||
RESTASIS | CYCLOSPORINE | EMULSION;OPHTHALMIC | 0.05% | Prescription | |||
NDA050775 - ABBVIE | |||||||
BIAXIN XL | CLARITHROMYCIN | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050749 - ABBVIE | |||||||
OMNICEF | CEFDINIR | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
OMNICEF | CEFDINIR | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050739 - ABBVIE | |||||||
OMNICEF | CEFDINIR | CAPSULE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050698 - ABBVIE | |||||||
BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 125MG/5ML | Discontinued | |||
BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 250MG/5ML | Discontinued | |||
BIAXIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 187MG/5ML | Discontinued | |||
NDA050697 - ABBVIE INC | |||||||
BIAXIN XL | CLARITHROMYCIN | TABLET;ORAL | 500MG | Prescription | |||
BIAXIN XL | CLARITHROMYCIN | TABLET;ORAL | 250MG | Prescription | |||
NDA050662 - ABBVIE | |||||||
BIAXIN | CLARITHROMYCIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BIAXIN | CLARITHROMYCIN | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDA040117 - ABBVIE | |||||||
VICODIN HP | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 660MG;10MG | Discontinued | |||
NDA022567 - ABBVIE | |||||||
VIIBRYD | VILAZODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | Prescription | |||
VIIBRYD | VILAZODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | Prescription | |||
VIIBRYD | VILAZODONE HYDROCHLORIDE | TABLET;ORAL | 40MG | Prescription | |||
NDA022548 - ABBVIE | |||||||
ZYMAXID | GATIFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.5% | Prescription | |||
NDA022525 - ABBVIE | |||||||
NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | Discontinued | |||
NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | Discontinued | |||
NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | Discontinued | |||
NDA022427 - ABBVIE | |||||||
ACUVAIL | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.45% | Prescription | |||
NDA022417 - ABBVIE | |||||||
NORVIR | RITONAVIR | TABLET;ORAL | 100MG | Prescription | |||
NDA022369 - ABBVIE | |||||||
LATISSE | BIMATOPROST | SOLUTION/DROPS;TOPICAL | 0.03% | Prescription | |||
NDA022315 - ABBVIE | |||||||
OZURDEX | DEXAMETHASONE | IMPLANT;INTRAVITREAL | 0.7MG | Prescription | |||
NDA022267 - ABBVIE INC | |||||||
DEPAKOTE ER | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE; ORAL | 250MG | Prescription | |||
DEPAKOTE ER | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE; ORAL | 500MG | Prescription | |||
NDA022256 - ABBVIE | |||||||
SAVELLA | MILNACIPRAN HYDROCHLORIDE | TABLET;ORAL | 12.5MG | Prescription | |||
SAVELLA | MILNACIPRAN HYDROCHLORIDE | TABLET;ORAL | 25MG | Prescription | |||
SAVELLA | MILNACIPRAN HYDROCHLORIDE | TABLET;ORAL | 100MG | Prescription | |||
SAVELLA | MILNACIPRAN HYDROCHLORIDE | TABLET;ORAL | 50MG | Prescription | |||
NDA022224 - ABBVIE | |||||||
TRILIPIX | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | Prescription | |||
TRILIPIX | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | Prescription | |||
NDA022206 - ABBVIE | |||||||
RAPAFLO | SILODOSIN | CAPSULE;ORAL | 4MG | Prescription | |||
RAPAFLO | SILODOSIN | CAPSULE;ORAL | 8MG | Prescription | |||
NDA022204 - ABBVIE | |||||||
GELNIQUE | OXYBUTYNIN CHLORIDE | GEL;TRANSDERMAL | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA022184 - ABBVIE | |||||||
LUMIGAN | BIMATOPROST | SOLUTION/DROPS;OPHTHALMIC | 0.01% | Prescription | |||
NDA022134 - ABBVIE | |||||||
LASTACAFT | ALCAFTADINE | SOLUTION/DROPS;OPHTHALMIC | 0.25% | Over-the-counter | |||
NDA021906 - ABBVIE | |||||||
KALETRA | LOPINAVIR; RITONAVIR | TABLET;ORAL | 200MG;50MG | Prescription | |||
KALETRA | LOPINAVIR; RITONAVIR | TABLET;ORAL | 100MG;25MG | Prescription | |||
NDA021883 - ABBVIE | |||||||
DALVANCE | DALBAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | Prescription | |||
NDA021830 - ABBVIE | |||||||
ASACOL HD | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021794 - ABBVIE | |||||||
ACZONE | DAPSONE | GEL;TOPICAL | 5% | Prescription | |||
NDA021770 - ABBVIE | |||||||
ALPHAGAN P | BRIMONIDINE TARTRATE | SOLUTION/DROPS;OPHTHALMIC | 0.1% | Prescription | |||
NDA021656 - ABBVIE | |||||||
TRICOR | FENOFIBRATE | TABLET;ORAL | 48MG | Discontinued | |||
TRICOR | FENOFIBRATE | TABLET;ORAL | 145MG | Discontinued | |||
NDA021606 - ABBVIE | |||||||
ZEMPLAR | PARICALCITOL | CAPSULE;ORAL | 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ZEMPLAR | PARICALCITOL | CAPSULE;ORAL | 2MCG | Prescription | |||
ZEMPLAR | PARICALCITOL | CAPSULE;ORAL | 1MCG | Prescription | |||
NDA021528 - ABBVIE | |||||||
ACULAR LS | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.4% | Prescription | |||
NDA021513 - ABBVIE | |||||||
ENABLEX | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ENABLEX | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021487 - ABBVIE | |||||||
NAMENDA | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Prescription | |||
NAMENDA | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Prescription | |||
NDA021402 - ABBVIE | |||||||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | |||
NDA021398 - ABBVIE | |||||||
COMBIGAN | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | 0.2%;EQ 0.5% BASE | Prescription | |||
NDA021365 - ABBVIE | |||||||
LEXAPRO | ESCITALOPRAM OXALATE | SOLUTION;ORAL | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021359 - ABBVIE | |||||||
RECTIV | NITROGLYCERIN | OINTMENT;INTRA-ANAL | 0.4% | Prescription | |||
NDA021323 - ABBVIE | |||||||
LEXAPRO | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 5MG BASE | Prescription | |||
LEXAPRO | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 10MG BASE | Prescription | |||
LEXAPRO | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
NDA021275 - ABBVIE | |||||||
LUMIGAN | BIMATOPROST | SOLUTION/DROPS;OPHTHALMIC | 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021268 - ABBVIE | |||||||
TEVETEN HCT | EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 600MG;12.5MG | Discontinued | |||
TEVETEN HCT | EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 600MG;25MG | Discontinued | |||
NDA021262 - ABBVIE | |||||||
ALPHAGAN P | BRIMONIDINE TARTRATE | SOLUTION/DROPS;OPHTHALMIC | 0.15% | Prescription | |||
NDA021252 - ABBVIE | |||||||
CANASA | MESALAMINE | SUPPOSITORY;RECTAL | 1GM | Prescription | |||
CANASA | MESALAMINE | SUPPOSITORY;RECTAL | 500MG | Discontinued | |||
NDA021251 - ABBVIE | |||||||
KALETRA | LOPINAVIR; RITONAVIR | SOLUTION;ORAL | 80MG/ML;20MG/ML | Prescription | |||
NDA021226 - ABBVIE | |||||||
KALETRA | LOPINAVIR; RITONAVIR | CAPSULE;ORAL | 133.3MG;33.3MG | Discontinued | |||
NDA021203 - ABBVIE | |||||||
TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021168 - ABBVIE | |||||||
DEPAKOTE ER | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | Prescription | |||
DEPAKOTE ER | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | Prescription | |||
NDA020945 - ABBVIE | |||||||
NORVIR | RITONAVIR | CAPSULE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020822 - ABBVIE | |||||||
CELEXA | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 10MG BASE | Prescription | |||
CELEXA | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 40MG BASE | Prescription | |||
CELEXA | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 60MG BASE | Discontinued | |||
CELEXA | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | Prescription | |||
NDA020819 - ABBVIE | |||||||
ZEMPLAR | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | Prescription | |||
ZEMPLAR | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | Prescription | |||
ZEMPLAR | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | Prescription | |||
NDA020738 - ABBVIE | |||||||
TEVETEN | EPROSARTAN MESYLATE | TABLET;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TEVETEN | EPROSARTAN MESYLATE | TABLET;ORAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TEVETEN | EPROSARTAN MESYLATE | TABLET;ORAL | EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BLA020725 - ABBVIE | |||||||
CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS | Prescription | |||
CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS | Prescription | |||
CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS | Prescription | |||
CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS | Prescription | |||
CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS | Prescription | |||
NDA020716 - ABBVIE | |||||||
VICOPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020708 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG | Prescription | |||
NDA020659 - ABBVIE | |||||||
NORVIR | RITONAVIR | SOLUTION;ORAL | 80MG/ML | Discontinued | |||
NDA020655 - ABBVIE | |||||||
ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | Discontinued | |||
ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | Discontinued | |||
ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | Discontinued | |||
ALORA | ESTRADIOL | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | Discontinued | |||
NDA020593 - ABBVIE | |||||||
DEPACON | VALPROATE SODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020591 - ABBVIE | |||||||
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2MG;180MG | Discontinued | |||
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 4MG;240MG | Discontinued | |||
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2MG;240MG | Discontinued | |||
NDA020551 - ABBVIE | |||||||
NIMBEX | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Discontinued | |||
NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Discontinued | |||
NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Discontinued | |||
NDA020528 - ABBVIE | |||||||
MAVIK | TRANDOLAPRIL | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
MAVIK | TRANDOLAPRIL | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
MAVIK | TRANDOLAPRIL | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020517 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 30MG | Prescription | |||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 45MG | Prescription | |||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 22.5MG | Prescription | |||
NDA020489 - ABBVIE | |||||||
ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 2.5MG/24HR | Discontinued | |||
ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MG/24HR | Discontinued | |||
NDA020478 - ABBVIE | |||||||
ULTANE | SEVOFLURANE | LIQUID;INHALATION | 100% | Prescription | |||
NDA020381 - ABBVIE | |||||||
NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 375MG | Discontinued | |||
NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NIASPAN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NIASPAN TITRATION STARTER PACK | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 375MG;500MG;750MG | Discontinued | |||
NDA020263 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 7.5MG | Prescription | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 11.25MG | Prescription | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 15MG | Prescription | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 11.25MG | Prescription | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 30MG | Prescription | |||
LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 45MG | Prescription | |||
NDA020200 - ABBVIE | |||||||
NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1.5MG/ML | Discontinued | |||
NDA020098 - ABBVIE | |||||||
MIVACRON | MIVACURIUM CHLORIDE | SOLUTION;INTRAVENOUS | EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
MIVACRON | MIVACURIUM CHLORIDE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | Discontinued | |||
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER | MIVACURIUM CHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/100ML | Discontinued | |||
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER | MIVACURIUM CHLORIDE | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | Discontinued | |||
MIVACRON | MIVACURIUM CHLORIDE | SOLUTION;INTRAVENOUS | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | Discontinued | |||
BLA020032 - ABBVIE | |||||||
SURVANTA | BERACTANT | SUSPENSION;INTRATRACHEAL | 25MG/ML | Prescription | |||
NDA020011 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG | Prescription | |||
NDA019946 - ABBVIE | |||||||
NUROMAX | DOXACURIUM CHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | Discontinued | |||
NDA019943 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE; INJECTION | 3.75MG | Prescription | |||
NDA019732 - ABBVIE ENDOCRINE INC | |||||||
LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG | Prescription | |||
NDA019700 - ABBVIE | |||||||
ACULAR | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | Prescription | |||
NDA019680 - ABBVIE | |||||||
DEPAKOTE | DIVALPROEX SODIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 125MG VALPROIC ACID | Prescription | |||
NDA019304 - ABBVIE | |||||||
TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LIPIDIL | FENOFIBRATE | CAPSULE;ORAL | 100MG | Discontinued | |||
TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019216 - ABBVIE | |||||||
FML FORTE | FLUOROMETHOLONE | SUSPENSION/DROPS;OPHTHALMIC | 0.25% | Prescription | |||
NDA019204 - ABBVIE | |||||||
CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 5MG | Discontinued | |||
CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
CARTROL | CARTEOLOL HYDROCHLORIDE | TABLET;ORAL | 2.5MG | Discontinued | |||
NDA019183 - ABBVIE | |||||||
CARAFATE | SUCRALFATE | SUSPENSION;ORAL | 1GM/10ML | Prescription | |||
NDA019010 - ABBVIE ENDOCRINE INC | |||||||
LUPRON | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018874 - ABBVIE | |||||||
CALCIJEX | CALCITRIOL | INJECTABLE;INJECTION | 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
CALCIJEX | CALCITRIOL | INJECTABLE;INJECTION | 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018723 - ABBVIE | |||||||
DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 500MG VALPROIC ACID | Prescription | |||
DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | Prescription | |||
DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | Prescription | |||
NDA018450 - ABBVIE | |||||||
NITROPRESS | SODIUM NITROPRUSSIDE | INJECTABLE;INJECTION | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018333 - ABBVIE | |||||||
CARAFATE | SUCRALFATE | TABLET;ORAL | 1GM | Prescription | |||
NDA018279 - ABBVIE | |||||||
K-TAB | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
K-TAB | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
K-TAB | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018117 - ABBVIE | |||||||
AZMACORT | TRIAMCINOLONE ACETONIDE | AEROSOL, METERED;INHALATION | 0.1MG/INH | Discontinued | |||
NDA018082 - ABBVIE | |||||||
DEPAKENE | VALPROIC ACID | SYRUP;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018081 - ABBVIE | |||||||
DEPAKENE | VALPROIC ACID | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA017100 - ABBVIE | |||||||
PRED MILD | PREDNISOLONE ACETATE | SUSPENSION/DROPS;OPHTHALMIC | 0.12% | Prescription | |||
NDA017011 - ABBVIE | |||||||
PRED FORTE | PREDNISOLONE ACETATE | SUSPENSION/DROPS;OPHTHALMIC | 1% | Prescription | |||
NDA016851 - ABBVIE | |||||||
FML | FLUOROMETHOLONE | SUSPENSION/DROPS;OPHTHALMIC | 0.1% | Prescription | |||
NDA012524 - ABBVIE | |||||||
ENDURON | METHYCLOTHIAZIDE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ENDURON | METHYCLOTHIAZIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA012418 - ABBVIE | |||||||
AKINETON | BIPERIDEN LACTATE | INJECTABLE;INJECTION | 5MG/ML | Discontinued | |||
NDA012302 - ABBVIE | |||||||
CHOLOXIN | DEXTROTHYROXINE SODIUM | TABLET;ORAL | 2MG | Discontinued | |||
CHOLOXIN | DEXTROTHYROXINE SODIUM | TABLET;ORAL | 4MG | Discontinued | |||
CHOLOXIN | DEXTROTHYROXINE SODIUM | TABLET;ORAL | 1MG | Discontinued | |||
CHOLOXIN | DEXTROTHYROXINE SODIUM | TABLET;ORAL | 6MG | Discontinued | |||
NDA012148 - ABBVIE | |||||||
ORETICYL 25 | DESERPIDINE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 0.125MG;25MG | Discontinued | |||
ORETICYL FORTE | DESERPIDINE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 0.25MG;25MG | Discontinued | |||
ORETICYL 50 | DESERPIDINE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 0.125MG;50MG | Discontinued | |||
NDA012003 - ABBVIE | |||||||
AKINETON | BIPERIDEN HYDROCHLORIDE | TABLET;ORAL | 2MG | Discontinued | |||
NDA011971 - ABBVIE | |||||||
ORETIC | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG | Discontinued | |||
ORETIC | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG | Discontinued | |||
NDA010796 - ABBVIE | |||||||
HARMONYL | DESERPIDINE | TABLET;ORAL | 0.1MG | Discontinued | |||
HARMONYL | DESERPIDINE | TABLET;ORAL | 0.25MG | Discontinued | |||
NDA010599 - ABBVIE | |||||||
TRAL | HEXOCYCLIUM METHYLSULFATE | TABLET;ORAL | 25MG | Discontinued | |||
NDA010021 - ABBVIE | |||||||
PLACIDYL | ETHCHLORVYNOL | CAPSULE;ORAL | 500MG | Discontinued | |||
PLACIDYL | ETHCHLORVYNOL | CAPSULE;ORAL | 100MG | Discontinued | |||
PLACIDYL | ETHCHLORVYNOL | CAPSULE;ORAL | 200MG | Discontinued | |||
PLACIDYL | ETHCHLORVYNOL | CAPSULE;ORAL | 750MG | Discontinued | |||
NDA008370 - ABBVIE | |||||||
BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
BENTYL | DICYCLOMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
NDA008322 - ABBVIE | |||||||
GEMONIL | METHARBITAL | TABLET;ORAL | 100MG | Discontinued | |||
NDA007707 - ABBVIE | |||||||
PHENURONE | PHENACEMIDE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA006905 - ABBVIE | |||||||
NORISODRINE | ISOPROTERENOL SULFATE | POWDER;INHALATION | 25% | Discontinued | |||
NORISODRINE | ISOPROTERENOL SULFATE | POWDER;INHALATION | 10% | Discontinued | |||
NDA006800 - ABBVIE | |||||||
PARADIONE | PARAMETHADIONE | CAPSULE;ORAL | 150MG | Discontinued | |||
PARADIONE | PARAMETHADIONE | CAPSULE;ORAL | 300MG | Discontinued | |||
PARADIONE | PARAMETHADIONE | SOLUTION;ORAL | 300MG/ML | Discontinued | |||
NDA006044 - ABBVIE | |||||||
DIASONE SODIUM | SULFOXONE SODIUM | TABLET, DELAYED RELEASE;ORAL | 165MG | Discontinued | |||
NDA005932 - ABBVIE | |||||||
AMINOSOL 5% | PROTEIN HYDROLYSATE | INJECTABLE;INJECTION | 5% | Discontinued | |||
NDA005856 - ABBVIE | |||||||
TRIDIONE | TRIMETHADIONE | CAPSULE;ORAL | 300MG | Discontinued | |||
TRIDIONE | TRIMETHADIONE | SOLUTION;ORAL | 200MG/5ML | Discontinued | |||
TRIDIONE | TRIMETHADIONE | TABLET;ORAL | 150MG | Discontinued | |||
NDA005545 - ABBVIE | |||||||
DICUMAROL | DICUMAROL | TABLET;ORAL | 25MG | Discontinued | |||
DICUMAROL | DICUMAROL | TABLET;ORAL | 50MG | Discontinued | |||
DICUMAROL | DICUMAROL | TABLET;ORAL | 100MG | Discontinued | |||
NDA004125 - ABBVIE | |||||||
SULFADIAZINE | SULFADIAZINE | TABLET;ORAL | 300MG | Discontinued |