Merck & Co., Inc. (MRK)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761363 - MERCK SHARP DOHME | |||||||
| WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 45MG | Prescription | |||
| WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | 60MG | Prescription | |||
| BLA761046 - MERCK SHARP DOHME | |||||||
| ZINPLAVA | BEZLOTOXUMAB | INJECTABLE;INJECTION | 1000ML/40ML | Prescription | |||
| NDA219104 - MSD | |||||||
| PREVYMIS | LETERMOVIR | PELLETS;ORAL | 20MG/PACKET | Prescription | |||
| PREVYMIS | LETERMOVIR | PELLETS;ORAL | 120MG/PACKET | Prescription | |||
| NDA215383 - MERCK SHARP DOHME | |||||||
| WELIREG | BELZUTIFAN | TABLET;ORAL | 40MG | Prescription | |||
| NDA214770 - MSD MERCK CO | |||||||
| NOXAFIL POWDERMIX KIT | POSACONAZOLE | FOR SUSPENSION, DELAYED RELEASE;ORAL | 300MG | Prescription | |||
| NDA214377 - MSD | |||||||
| VERQUVO | VERICIGUAT | TABLET;ORAL | 10MG | Prescription | |||
| VERQUVO | VERICIGUAT | TABLET;ORAL | 2.5MG | Prescription | |||
| VERQUVO | VERICIGUAT | TABLET;ORAL | 5MG | Prescription | |||
| NDA212819 - MSD MERCK CO | |||||||
| RECARBRIO | CILASTATIN SODIUM; IMIPENEM; RELEBACTAM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | Prescription | |||
| NDA210807 - MSD MERCK CO | |||||||
| DELSTRIGO | DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 100MG;300MG;300MG | Prescription | |||
| NDA210806 - MSD MERCK CO | |||||||
| PIFELTRO | DORAVIRINE | TABLET;ORAL | 100MG | Prescription | |||
| NDA210365 - JAZZ PHARMS RES | |||||||
| EPIDIOLEX | CANNABIDIOL | SOLUTION;ORAL | 100MG/ML | Prescription | |||
| NDA209940 - MERCK SHARP DOHME | |||||||
| PREVYMIS | LETERMOVIR | SOLUTION;INTRAVENOUS | 480MG/24ML (20MG/ML) | Prescription | |||
| PREVYMIS | LETERMOVIR | SOLUTION;INTRAVENOUS | 240MG/12ML (20MG/ML) | Prescription | |||
| NDA209939 - MERCK SHARP DOHME | |||||||
| PREVYMIS | LETERMOVIR | TABLET;ORAL | 480MG | Prescription | |||
| PREVYMIS | LETERMOVIR | TABLET;ORAL | 240MG | Prescription | |||
| NDA209806 - MSD SUB MERCK | |||||||
| SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | Prescription | |||
| SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;1GM | Prescription | |||
| SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 7.5MG;500MG | Prescription | |||
| SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 7.5MG;1GM | Prescription | |||
| NDA209805 - MSD SUB MERCK | |||||||
| STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 15MG;EQ 100MG BASE | Prescription | |||
| STEGLUJAN | ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 5MG;EQ 100MG BASE | Prescription | |||
| NDA209803 - MSD SUB MERCK | |||||||
| STEGLATRO | ERTUGLIFLOZIN | TABLET;ORAL | 5MG | Prescription | |||
| STEGLATRO | ERTUGLIFLOZIN | TABLET;ORAL | 15MG | Prescription | |||
| NDA209764 - MERCK SHARP DOHME | |||||||
| NDA208261 - MSD SUB MERCK | |||||||
| ZEPATIER | ELBASVIR; GRAZOPREVIR | TABLET;ORAL | 50MG;100MG | Prescription | |||
| NDA208114 - JAZZ PHARMS INC | |||||||
| DEFITELIO | DEFIBROTIDE SODIUM | SOLUTION;INTRAVENOUS | 200MG/2.5ML (80MG/ML) | Prescription | |||
| NDA207865 - MSD MERCK CO | |||||||
| EMEND | APREPITANT | FOR SUSPENSION;ORAL | 125MG/KIT | Prescription | |||
| NDA206510 - MERCK SHARP DOHME | |||||||
| DUTREBIS | LAMIVUDINE; RALTEGRAVIR POTASSIUM | TABLET;ORAL | 150MG;EQ 300MG BASE | Discontinued | |||
| NDA205786 - MSD SUB MERCK | |||||||
| ISENTRESS | RALTEGRAVIR POTASSIUM | POWDER;ORAL | EQ 100MG BASE/PACKET | Prescription | |||
| NDA205596 - MERCK SHARP DOHME | |||||||
| NOXAFIL | POSACONAZOLE | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | Prescription | |||
| NDA205053 - MERCK SHARP DOHME | |||||||
| NOXAFIL | POSACONAZOLE | TABLET, DELAYED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA204569 - MERCK SHARP DOHME | |||||||
| BELSOMRA | SUVOREXANT | TABLET;ORAL | 20MG | Prescription | |||
| BELSOMRA | SUVOREXANT | TABLET;ORAL | 15MG | Prescription | |||
| BELSOMRA | SUVOREXANT | TABLET;ORAL | 10MG | Prescription | |||
| BELSOMRA | SUVOREXANT | TABLET;ORAL | 5MG | Prescription | |||
| NDA203045 - MSD SUB MERCK | |||||||
| ISENTRESS | RALTEGRAVIR POTASSIUM | TABLET, CHEWABLE;ORAL | EQ 25MG BASE | Prescription | |||
| ISENTRESS | RALTEGRAVIR POTASSIUM | TABLET, CHEWABLE;ORAL | EQ 100MG BASE | Prescription | |||
| NDA202343 - MERCK SHARP DOHME | |||||||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| JUVISYNC | SIMVASTATIN; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA202270 - MSD SUB MERCK | |||||||
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | TABLET, EXTENDED RELEASE;ORAL | 500MG;EQ 50MG BASE | Prescription | |||
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 50MG BASE | Prescription | |||
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 100MG BASE | Prescription | |||
| NDA202258 - MERCK SHARP DOHME | |||||||
| VICTRELIS | BOCEPREVIR | CAPSULE;ORAL | 200MG | Discontinued | |||
| BLA125514 - MERCK SHARP DOHME | |||||||
| KEYTRUDA | PEMBROLIZUMAB | SOLUTION;INTRAVENOUS | 100MG/4ML (25MG/ML) | Prescription | |||
| BLA103949 - SCHERING | |||||||
| PEGINTRON | PEGINTERFERON ALFA-2B | VIAL | 50UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | VIAL | 150UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | SYRINGE | 80UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | SYRINGE | 150UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | SYRINGE | 120UG/0.5ML | Prescription | |||
| SYLATRON | PEGINTERFERON ALFA-2B | VIAL | 296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL | Prescription | |||
| SYLATRON | PEGINTERFERON ALFA-2B | VIAL | 444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL | Prescription | |||
| SYLATRON | PEGINTERFERON ALFA-2B | VIAL | 888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | VIAL | 120UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | VIAL | 80UG/0.5ML | Prescription | |||
| PEGINTRON | PEGINTERFERON ALFA-2B | SYRINGE | 50UG/0.5ML | Prescription | |||
| BLA103132 - SCHERING | |||||||
| INTRON A | INTERFERON ALFA-2B | VIAL | 10MIU/VIAL | Prescription | |||
| INTRON A | INTERFERON ALFA-2B | VIAL | 18MIU/VIAL | Prescription | |||
| INTRON A | INTERFERON ALFA-2B | VIAL | 25MIU/VIAL | Prescription | |||
| BLA101063 - MERCK | |||||||
| ELSPAR | ASPARAGINASE | VIAL | 10,000IU/VIAL | Prescription | |||
| ANDA089823 - SCHERING | |||||||
| UNI-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 600MG | Discontinued | |||
| ANDA089822 - SCHERING | |||||||
| UNI-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | Discontinued | |||
| ANDA089131 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 450MG | Discontinued | |||
| ANDA088022 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | Discontinued | |||
| ANDA088016 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | Discontinued | |||
| ANDA088015 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | Discontinued | |||
| ANDA087995 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Discontinued | |||
| ANDA087910 - SCHERING | |||||||
| THEOVENT | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 250MG | Discontinued | |||
| ANDA087010 - SCHERING | |||||||
| THEOVENT | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | Discontinued | |||
| ANDA086998 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Discontinued | |||
| ANDA086837 - SCHERING | |||||||
| POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | SYRUP;ORAL | 2MG/5ML | Discontinued | |||
| ANDA086835 - SCHERING | |||||||
| POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | TABLET;ORAL | 2MG | Discontinued | |||
| ANDA085328 - SCHERING | |||||||
| THEO-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| THEO-DUR | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANDA085222 - SCHERING | |||||||
| QUINORA | QUINIDINE SULFATE | TABLET;ORAL | 300MG | Discontinued | |||
| ANDA083834 - SCHERING | |||||||
| METRETON | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% PHOSPHATE | Discontinued | |||
| ANDA080778 - MERCK | |||||||
| ALPHAREDISOL | HYDROXOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
| ANDA080381 - SCHERING | |||||||
| TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 5MG | Discontinued | |||
| TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 2MG | Discontinued | |||
| ANDA080281 - SCHERING | |||||||
| ORETON | METHYLTESTOSTERONE | TABLET;BUCCAL | 10MG | Discontinued | |||
| ANDA070598 - SCHERING | |||||||
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | Discontinued | |||
| ANDA070124 - SCHERING | |||||||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 80MG | Discontinued | |||
| ANDA070123 - SCHERING | |||||||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 60MG | Discontinued | |||
| ANDA070122 - SCHERING | |||||||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 40MG | Discontinued | |||
| ANDA070121 - SCHERING | |||||||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG | Discontinued | |||
| ANDA070120 - SCHERING | |||||||
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| ANDA062756 - MERCK | |||||||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL;250MG/VIAL | Discontinued | |||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL;500MG/VIAL | Discontinued | |||
| ANDA062302 - SCHERING | |||||||
| OTOBIOTIC | HYDROCORTISONE; POLYMYXIN B SULFATE | SOLUTION/DROPS;OTIC | 5MG/ML;EQ 10,000 UNITS BASE/ML | Discontinued | |||
| ANDA061816 - SCHERING | |||||||
| OTOBIONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SUSPENSION/DROPS;OTIC | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | Discontinued | |||
| ANDA061739 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANDA061716 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| GARAMYCIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANDA060463 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | OINTMENT;TOPICAL | EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ANDA060462 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | CREAM;TOPICAL | EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050742 - MERCK SHARP DOHME | |||||||
| STROMECTOL | IVERMECTIN | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| STROMECTOL | IVERMECTIN | TABLET;ORAL | 3MG | Prescription | |||
| NDA050630 - MERCK | |||||||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | POWDER;INTRAMUSCULAR | EQ 500MG BASE/VIAL;500MG/VIAL | Discontinued | |||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | POWDER;INTRAMUSCULAR | EQ 750MG BASE/VIAL;750MG/VIAL | Discontinued | |||
| NDA050587 - MERCK | |||||||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL;500MG/VIAL | Prescription | |||
| NDA050581 - MERCK | |||||||
| MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050544 - SCHERING | |||||||
| NETROMYCIN | NETILMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Discontinued | |||
| NETROMYCIN | NETILMICIN SULFATE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | Discontinued | |||
| NETROMYCIN | NETILMICIN SULFATE | INJECTABLE;INJECTION | EQ 25MG BASE/ML | Discontinued | |||
| NDA050505 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | INJECTABLE;INTRATHECAL | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA050425 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | OINTMENT;OPHTHALMIC | EQ 0.3% BASE | Discontinued | |||
| NDA050378 - MERCK | |||||||
| NEO-HYDELTRASOL | NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE | OINTMENT;OPHTHALMIC | EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE | Discontinued | |||
| NDA050324 - MERCK | |||||||
| NEODECADRON | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | OINTMENT;OPHTHALMIC | EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM | Discontinued | |||
| NDA050322 - MERCK | |||||||
| NEODECADRON | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML | Discontinued | |||
| NDA050039 - SCHERING | |||||||
| GARAMYCIN | GENTAMICIN SULFATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA022277 - MERCK SHARP DOHME | |||||||
| TEMODAR | TEMOZOLOMIDE | POWDER;INTRAVENOUS | 100MG/VIAL | Prescription | |||
| NDA022225 - MSD SUB MERCK | |||||||
| BRIDION | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | Prescription | |||
| BRIDION | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | Prescription | |||
| NDA022145 - MSD SUB MERCK | |||||||
| ISENTRESS | RALTEGRAVIR POTASSIUM | TABLET;ORAL | EQ 400MG BASE | Prescription | |||
| ISENTRESS HD | RALTEGRAVIR POTASSIUM | TABLET;ORAL | EQ 600MG BASE | Prescription | |||
| NDA022044 - MSD SUB MERCK | |||||||
| JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 500MG;EQ 50MG BASE | Prescription | |||
| JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | TABLET;ORAL | 1GM;EQ 50MG BASE | Prescription | |||
| NDA022027 - SCHERING | |||||||
| NOXAFIL | POSACONAZOLE | SUSPENSION; ORAL | 40MG/ML | Prescription | |||
| NDA022023 - MERCK AND CO INC | |||||||
| EMEND | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| EMEND | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 150MG BASE/VIAL | Prescription | |||
| NDA022003 - SCHERING | |||||||
| NOXAFIL | POSACONAZOLE | SUSPENSION;ORAL | 40MG/ML | Prescription | |||
| NDA021995 - MERCK SHARP DOHME | |||||||
| JANUVIA | SITAGLIPTIN PHOSPHATE | TABLET;ORAL | EQ 50MG BASE | Prescription | |||
| JANUVIA | SITAGLIPTIN PHOSPHATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
| JANUVIA | SITAGLIPTIN PHOSPHATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
| NDA021991 - MSD SUB MERCK | |||||||
| ZOLINZA | VORINOSTAT | CAPSULE;ORAL | 100MG | Prescription | |||
| NDA021647 - MERCK | |||||||
| VIOXX | ROFECOXIB | TABLET; ORAL | 25MG | Discontinued | |||
| VIOXX | ROFECOXIB | TABLET; ORAL | 50MG | Discontinued | |||
| VIOXX | ROFECOXIB | TABLET; ORAL | 12.5MG | Discontinued | |||
| NDA021575 - MERCK | |||||||
| FOSAMAX | ALENDRONATE SODIUM | SOLUTION;ORAL | EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021563 - SCHERING | |||||||
| CLARINEX | DESLORATADINE | SYRUP; ORAL | 0.5MG/ML | Prescription | |||
| NDA021549 - MERCK | |||||||
| EMEND | APREPITANT | CAPSULE;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| EMEND | APREPITANT | CAPSULE;ORAL | 80MG | Prescription | |||
| EMEND | APREPITANT | CAPSULE;ORAL | 125MG | Prescription | |||
| NDA021546 - SCHERING | |||||||
| REBETOL | RIBAVIRIN | SOLUTION;ORAL | 40MG/ML | Discontinued | |||
| NDA021363 - SCHERING | |||||||
| CLARINEX | DESLORATADINE | Tablet; Oral | 5MG | Prescription | |||
| NDA021337 - MSD SUB MERCK | |||||||
| INVANZ | ERTAPENEM SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 1GM BASE/VIAL | Prescription | |||
| NDA021300 - MERCK SHARP DOHME | |||||||
| CLARINEX | DESLORATADINE | SOLUTION;ORAL | 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA021297 - SCHERING | |||||||
| CLARINEX | DESLORATADINE | Tablet; Oral | 5MG | Prescription | |||
| NDA021227 - MERCK | |||||||
| CANCIDAS | CASPOFUNGIN ACETATE | POWDER;INTRAVENOUS | 50MG/VIAL | Prescription | |||
| CANCIDAS | CASPOFUNGIN ACETATE | POWDER;INTRAVENOUS | 70MG/VIAL | Prescription | |||
| NDA021052 - MERCK | |||||||
| VIOXX | ROFECOXIB | SUSPENSION;ORAL | 25MG/5ML | Discontinued | |||
| VIOXX | ROFECOXIB | SUSPENSION;ORAL | 12.5MG/5ML | Discontinued | |||
| NDA021042 - MERCK | |||||||
| VIOXX | ROFECOXIB | TABLET;ORAL | 12.5MG | Discontinued | |||
| VIOXX | ROFECOXIB | TABLET;ORAL | 25MG | Discontinued | |||
| VIOXX | ROFECOXIB | TABLET;ORAL | 50MG | Discontinued | |||
| NDA021029 - MERCK SHARP DOHME | |||||||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | Discontinued | |||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | Discontinued | |||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | Discontinued | |||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | Discontinued | |||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | Discontinued | |||
| TEMODAR | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | Discontinued | |||
| NDA020903 - MERCK SHARP DOHME | |||||||
| REBETOL | RIBAVIRIN | CAPSULE;ORAL | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** | Discontinued | |||
| REBETOL | RIBAVIRIN | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020752 - MERCK | |||||||
| PEPCID RPD | FAMOTIDINE | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | Discontinued | |||
| PEPCID RPD | FAMOTIDINE | TABLET, ORALLY DISINTEGRATING;ORAL | 40MG | Discontinued | |||
| NDA020718 - MSD SUB MERCK | |||||||
| INTEGRILIN | EPTIFIBATIDE | INJECTABLE;INJECTION | 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| INTEGRILIN | EPTIFIBATIDE | INJECTABLE;INJECTION | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020685 - MERCK SHARP DOHME | |||||||
| CRIXIVAN | INDINAVIR SULFATE | CAPSULE;ORAL | EQ 100MG BASE | Discontinued | |||
| CRIXIVAN | INDINAVIR SULFATE | CAPSULE;ORAL | EQ 333MG BASE | Discontinued | |||
| CRIXIVAN | INDINAVIR SULFATE | CAPSULE;ORAL | EQ 400MG BASE | Discontinued | |||
| CRIXIVAN | INDINAVIR SULFATE | CAPSULE;ORAL | EQ 200MG BASE | Discontinued | |||
| NDA020506 - MERCK | |||||||
| TIAMATE | DILTIAZEM MALATE | TABLET, EXTENDED RELEASE;ORAL | EQ 120MG HYDROCHLORIDE | Discontinued | |||
| TIAMATE | DILTIAZEM MALATE | TABLET, EXTENDED RELEASE;ORAL | EQ 180MG HYDROCHLORIDE | Discontinued | |||
| TIAMATE | DILTIAZEM MALATE | TABLET, EXTENDED RELEASE;ORAL | EQ 240MG HYDROCHLORIDE | Discontinued | |||
| NDA020486 - SCHERING | |||||||
| VANCERIL DOUBLE STRENGTH | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.084MG/INH | Discontinued | |||
| NDA020469 - SCHERING | |||||||
| VANCENASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | SPRAY, METERED;NASAL | EQ 0.084MG DIPROP/SPRAY | Discontinued | |||
| NDA020408 - MSD SUB MERCK | |||||||
| TRUSOPT | DORZOLAMIDE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020249 - MERCK SHARP DOHME | |||||||
| PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER | FAMOTIDINE | INJECTABLE;INJECTION | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA020240 - SCHERING | |||||||
| RENORMAX | SPIRAPRIL HYDROCHLORIDE | TABLET;ORAL | 6MG | Discontinued | |||
| RENORMAX | SPIRAPRIL HYDROCHLORIDE | TABLET;ORAL | 12MG | Discontinued | |||
| RENORMAX | SPIRAPRIL HYDROCHLORIDE | TABLET;ORAL | 24MG | Discontinued | |||
| RENORMAX | SPIRAPRIL HYDROCHLORIDE | TABLET;ORAL | 3MG | Discontinued | |||
| NDA020010 - MERCK SHARP DOHME | |||||||
| LOTRISONE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | LOTION;TOPICAL | EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019778 - MERCK | |||||||
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019757 - MERCK | |||||||
| CHIBROXIN | NORFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.3% | Discontinued | |||
| NDA019643 - MERCK | |||||||
| MEVACOR | LOVASTATIN | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEVACOR | LOVASTATIN | TABLET;ORAL | 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| MEVACOR | LOVASTATIN | TABLET;ORAL | 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019589 - SCHERING | |||||||
| VANCENASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | SPRAY, METERED;NASAL | EQ 0.042MG DIPROP/SPRAY | Discontinued | |||
| NDA019558 - MERCK | |||||||
| PRINIVIL | LISINOPRIL | TABLET;ORAL | 5MG | Discontinued | |||
| PRINIVIL | LISINOPRIL | TABLET;ORAL | 10MG | Discontinued | |||
| PRINIVIL | LISINOPRIL | TABLET;ORAL | 40MG | Discontinued | |||
| PRINIVIL | LISINOPRIL | TABLET;ORAL | 2.5MG | Discontinued | |||
| PRINIVIL | LISINOPRIL | TABLET;ORAL | 20MG | Discontinued | |||
| NDA019510 - MERCK | |||||||
| PEPCID | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PEPCID PRESERVATIVE FREE | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019439 - SCHERING | |||||||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019408 - SCHERING | |||||||
| DIPROLENE | BETAMETHASONE DIPROPIONATE | CREAM, AUGMENTED;TOPICAL | EQ 0.05% BASE | Discontinued | |||
| DIPROLENE | BETAMETHASONE DIPROPIONATE | GEL, AUGMENTED;TOPICAL | EQ 0.05% BASE | Discontinued | |||
| NDA019384 - MERCK | |||||||
| NOROXIN | NORFLOXACIN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019383 - SCHERING | |||||||
| PROVENTIL | ALBUTEROL SULFATE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | Discontinued | |||
| NDA019243 - SCHERING | |||||||
| PROVENTIL | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROVENTIL | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA019046 - SCHERING | |||||||
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;100MG | Discontinued | |||
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;200MG | Discontinued | |||
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;300MG | Discontinued | |||
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;400MG | Discontinued | |||
| NDA018813 - SCHERING | |||||||
| LOTRIMIN | CLOTRIMAZOLE | LOTION;TOPICAL | 1% | Discontinued | |||
| NDA018687 - SCHERING | |||||||
| NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NORMODYNE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018686 - SCHERING | |||||||
| NORMODYNE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018554 - SCHERING | |||||||
| EULEXIN | FLUTAMIDE | CAPSULE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018521 - SCHERING | |||||||
| VANCENASE | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;NASAL | 0.042MG/INH | Discontinued | |||
| NDA018506 - SCHERING | |||||||
| TRINALIN | AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 1MG;120MG | Discontinued | |||
| NDA018445 - MERCK | |||||||
| DOLOBID | DIFLUNISAL | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DOLOBID | DIFLUNISAL | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018389 - MERCK | |||||||
| ALDOMET | METHYLDOPA | SUSPENSION;ORAL | 250MG/5ML | Discontinued | |||
| NDA018201 - MERCK | |||||||
| MODURETIC 5-50 | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 5MG ANHYDROUS;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018062 - SCHERING | |||||||
| PROVENTIL | ALBUTEROL SULFATE | SYRUP;ORAL | EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA018061 - MERCK | |||||||
| TIMOLIDE 10-25 | HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE | TABLET;ORAL | 25MG;10MG | Discontinued | |||
| NDA018017 - MERCK | |||||||
| BLOCADREN | TIMOLOL MALEATE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| BLOCADREN | TIMOLOL MALEATE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| BLOCADREN | TIMOLOL MALEATE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017911 - MERCK | |||||||
| CLINORIL | SULINDAC | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| CLINORIL | SULINDAC | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017853 - SCHERING | |||||||
| PROVENTIL | ALBUTEROL SULFATE | TABLET;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| PROVENTIL | ALBUTEROL SULFATE | TABLET;ORAL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017829 - SCHERING | |||||||
| DIPROSONE | BETAMETHASONE DIPROPIONATE | DISC;TOPICAL | EQ 0.1% BASE | Discontinued | |||
| NDA017781 - SCHERING | |||||||
| DIPROSONE | BETAMETHASONE DIPROPIONATE | LOTION;TOPICAL | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017736 - SCHERING | |||||||
| PAXIPAM | HALAZEPAM | TABLET;ORAL | 40MG | Discontinued | |||
| PAXIPAM | HALAZEPAM | TABLET;ORAL | 20MG | Discontinued | |||
| NDA017691 - SCHERING | |||||||
| DIPROSONE | BETAMETHASONE DIPROPIONATE | OINTMENT;TOPICAL | EQ 0.05% BASE | Discontinued | |||
| NDA017601 - SCHERING | |||||||
| OPTIMINE | AZATADINE MALEATE | TABLET;ORAL | 1MG | Discontinued | |||
| NDA017573 - SCHERING | |||||||
| VANCERIL | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.042MG/INH | Discontinued | |||
| NDA017561 - SCHERING | |||||||
| CELESTONE | BETAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA017559 - SCHERING | |||||||
| PROVENTIL | ALBUTEROL | AEROSOL, METERED;INHALATION | 0.09MG/INH | Discontinued | |||
| NDA017536 - SCHERING | |||||||
| DIPROSONE | BETAMETHASONE DIPROPIONATE | CREAM;TOPICAL | EQ 0.05% BASE | Discontinued | |||
| NDA017460 - CALGON | |||||||
| SEPTI-SOFT | HEXACHLOROPHENE | SOLUTION;TOPICAL | 0.25% | Discontinued | |||
| NDA016996 - SCHERING | |||||||
| HYPERSTAT | DIAZOXIDE | INJECTABLE;INJECTION | 15MG/ML | Discontinued | |||
| NDA016932 - SCHERING | |||||||
| VALISONE | BETAMETHASONE VALERATE | LOTION;TOPICAL | EQ 0.1% BASE | Discontinued | |||
| NDA016740 - SCHERING | |||||||
| VALISONE | BETAMETHASONE VALERATE | OINTMENT;TOPICAL | EQ 0.1% BASE | Discontinued | |||
| NDA016675 - MERCK | |||||||
| DECADRON-LA | DEXAMETHASONE ACETATE | INJECTABLE;INJECTION | EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA016322 - SCHERING | |||||||
| VALISONE | BETAMETHASONE VALERATE | CREAM;TOPICAL | EQ 0.1% BASE | Discontinued | |||
| VALISONE | BETAMETHASONE VALERATE | CREAM;TOPICAL | EQ 0.01% BASE | Discontinued | |||
| NDA016097 - MERCK SHARP DOHME | |||||||
| MINTEZOL | THIABENDAZOLE | SUSPENSION;ORAL | 500MG/5ML | Discontinued | |||
| NDA016096 - MERCK SHARP DOHME | |||||||
| MINTEZOL | THIABENDAZOLE | TABLET, CHEWABLE;ORAL | 500MG | Discontinued | |||
| NDA016053 - SCHERING | |||||||
| BETAPAR | MEPREDNISONE | TABLET;ORAL | 4MG | Discontinued | |||
| NDA016016 - MERCK | |||||||
| ALDOCLOR-150 | CHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 150MG;250MG | Discontinued | |||
| ALDOCLOR-250 | CHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 250MG;250MG | Discontinued | |||
| NDA016008 - SCHERING | |||||||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA014762 - SCHERING | |||||||
| CELESTONE | BETAMETHASONE | CREAM;TOPICAL | 0.2% | Discontinued | |||
| NDA014713 - SCHERING | |||||||
| ETRAFON 2-25 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | TABLET;ORAL | 25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ETRAFON-FORTE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | TABLET;ORAL | 25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ETRAFON-A | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | TABLET;ORAL | 10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ETRAFON 2-10 | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | TABLET;ORAL | 10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA014215 - MERCK SHARP DOHME | |||||||
| CELESTONE | BETAMETHASONE | SYRUP;ORAL | 0.6MG/5ML | Discontinued | |||
| NDA013538 - MERCK | |||||||
| DECADERM | DEXAMETHASONE | GEL;TOPICAL | 0.1% | Discontinued | |||
| NDA013402 - MERCK | |||||||
| ALDORIL 15 | HYDROCHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 15MG;250MG | Discontinued | |||
| ALDORIL 25 | HYDROCHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 25MG;250MG | Discontinued | |||
| ALDORIL D30 | HYDROCHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 30MG;500MG | Discontinued | |||
| ALDORIL D50 | HYDROCHLOROTHIAZIDE; METHYLDOPA | TABLET;ORAL | 50MG;500MG | Discontinued | |||
| NDA013401 - MERCK | |||||||
| ALDOMET | METHYLDOPATE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA013400 - MERCK | |||||||
| ALDOMET | METHYLDOPA | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALDOMET | METHYLDOPA | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| ALDOMET | METHYLDOPA | TABLET;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA013334 - MERCK | |||||||
| DECADRON W/ XYLOCAINE | DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML;10MG/ML | Discontinued | |||
| NDA013220 - MERCK | |||||||
| PERIACTIN | CYPROHEPTADINE HYDROCHLORIDE | SYRUP;ORAL | 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012731 - MERCK | |||||||
| DECASPRAY | DEXAMETHASONE | AEROSOL;TOPICAL | 0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012657 - SCHERING | |||||||
| CELESTONE | BETAMETHASONE | TABLET;ORAL | 0.6MG | Discontinued | |||
| NDA012649 - MERCK | |||||||
| PERIACTIN | CYPROHEPTADINE HYDROCHLORIDE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012470 - SCHERING | |||||||
| AKRINOL | ACRISORCIN | CREAM;TOPICAL | 2MG/GM | Discontinued | |||
| NDA012419 - SCHERING | |||||||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1MG | Discontinued | |||
| NDA012394 - SCHERING | |||||||
| DISOPHROL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | TABLET;ORAL | 2MG;60MG | Discontinued | |||
| NDA012383 - MERCK | |||||||
| COLBENEMID | COLCHICINE; PROBENECID | TABLET;ORAL | 0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012376 - MERCK | |||||||
| DECADRON | DEXAMETHASONE | ELIXIR;ORAL | 0.5MG/5ML | Discontinued | |||
| NDA012265 - SCHERING | |||||||
| NAQUA | TRICHLORMETHIAZIDE | TABLET;ORAL | 4MG | Discontinued | |||
| NAQUA | TRICHLORMETHIAZIDE | TABLET;ORAL | 2MG | Discontinued | |||
| NAQUIVAL | RESERPINE; TRICHLORMETHIAZIDE | TABLET;ORAL | 0.1MG;4MG | Discontinued | |||
| NDA012254 - SCHERING | |||||||
| TINDAL | ACETOPHENAZINE MALEATE | TABLET;ORAL | 20MG | Discontinued | |||
| NDA012155 - SCHERING | |||||||
| RELA | CARISOPRODOL | TABLET;ORAL | 350MG | Discontinued | |||
| NDA012071 - MERCK | |||||||
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012052 - MERCK | |||||||
| HYDROCORTONE | HYDROCORTISONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA012034 - SCHERING | |||||||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 0.25MG | Discontinued | |||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | Discontinued | |||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | Discontinued | |||
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA011984 - MERCK | |||||||
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC, OTIC | EQ 0.1% PHOSPHATE | Discontinued | |||
| NDA011983 - MERCK | |||||||
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | CREAM;TOPICAL | EQ 0.1% PHOSPHATE | Discontinued | |||
| NDA011977 - MERCK | |||||||
| DECADRON | DEXAMETHASONE SODIUM PHOSPHATE | OINTMENT;OPHTHALMIC | EQ 0.05% PHOSPHATE | Discontinued | |||
| NDA011958 - MERCK | |||||||
| HYDROPRES 25 | HYDROCHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 25MG;0.125MG | Discontinued | |||
| HYDROPRES 50 | HYDROCHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 50MG;0.125MG | Discontinued | |||
| NDA011860 - MERCK | |||||||
| HUMORSOL | DEMECARIUM BROMIDE | SOLUTION/DROPS;OPHTHALMIC | 0.25% | Discontinued | |||
| HUMORSOL | DEMECARIUM BROMIDE | SOLUTION/DROPS;OPHTHALMIC | 0.125% | Discontinued | |||
| NDA011835 - MERCK | |||||||
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011814 - SCHERING | |||||||
| DISOMER | DEXBROMPHENIRAMINE MALEATE | SYRUP;ORAL | 2MG/5ML | Discontinued | |||
| DISOMER | DEXBROMPHENIRAMINE MALEATE | TABLET;ORAL | 2MG | Discontinued | |||
| NDA011664 - MERCK | |||||||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| DECADRON | DEXAMETHASONE | TABLET;ORAL | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA011635 - MERCK | |||||||
| DIUPRES-250 | CHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 250MG;0.125MG | Discontinued | |||
| DIUPRES-500 | CHLOROTHIAZIDE; RESERPINE | TABLET;ORAL | 500MG;0.125MG | Discontinued | |||
| NDA011583 - MERCK | |||||||
| HYDELTRASOL | PREDNISOLONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 20MG PHOSPHATE/ML | Discontinued | |||
| NDA011557 - SCHERING | |||||||
| TRILAFON | PERPHENAZINE | CONCENTRATE;ORAL | 16MG/5ML | Discontinued | |||
| NDA011361 - SCHERING | |||||||
| TRILAFON | PERPHENAZINE | TABLET, EXTENDED RELEASE;ORAL | 8MG | Discontinued | |||
| NDA011294 - SCHERING | |||||||
| TRILAFON | PERPHENAZINE | SYRUP;ORAL | 2MG/5ML | Discontinued | |||
| NDA011213 - SCHERING | |||||||
| TRILAFON | PERPHENAZINE | INJECTABLE;INJECTION | 5MG/ML | Discontinued | |||
| NDA011028 - MERCK | |||||||
| HYDELTRASOL | PREDNISOLONE SODIUM PHOSPHATE | OINTMENT;OPHTHALMIC, OTIC | EQ 0.25% PHOSPHATE | Discontinued | |||
| NDA010909 - SCHERING | |||||||
| MIRADON | ANISINDIONE | TABLET;ORAL | 50MG | Discontinued | |||
| NDA010775 - SCHERING | |||||||
| TRILAFON | PERPHENAZINE | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRILAFON | PERPHENAZINE | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRILAFON | PERPHENAZINE | TABLET;ORAL | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| TRILAFON | PERPHENAZINE | TABLET;ORAL | 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA010656 - MERCK | |||||||
| FLOROPRYL | ISOFLUROPHATE | OINTMENT;OPHTHALMIC | 0.025% | Discontinued | |||
| NDA010585 - MERCK | |||||||
| LERITINE | ANILERIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | Discontinued | |||
| NDA010562 - MERCK | |||||||
| HYDELTRA-TBA | PREDNISOLONE TEBUTATE | INJECTABLE;INJECTION | 20MG/ML | Discontinued | |||
| NDA010520 - MERCK | |||||||
| LERITINE | ANILERIDINE PHOSPHATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA010255 - SCHERING | |||||||
| METICORTELONE | PREDNISOLONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| NDA010210 - SCHERING | |||||||
| METIMYD | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | SUSPENSION/DROPS;OPHTHALMIC | 0.5%;10% | Discontinued | |||
| METIMYD | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | OINTMENT;OPHTHALMIC | 0.5%;10% | Discontinued | |||
| NDA010209 - SCHERING | |||||||
| METI-DERM | PREDNISOLONE | CREAM;TOPICAL | 0.5% | Discontinued | |||
| NDA009766 - SCHERING | |||||||
| METICORTEN | PREDNISONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| METICORTEN | PREDNISONE | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA009509 - MERCK | |||||||
| ARAMINE | METARAMINOL BITARTRATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA009193 - MERCK | |||||||
| COGENTIN | BENZTROPINE MESYLATE | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| COGENTIN | BENZTROPINE MESYLATE | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| COGENTIN | BENZTROPINE MESYLATE | TABLET;ORAL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA009018 - MERCK | |||||||
| HYDROCORTONE | HYDROCORTISONE ACETATE | OINTMENT;OPHTHALMIC, OTIC | 1.5% | Discontinued | |||
| NDA008506 - MERCK | |||||||
| HYDROCORTONE | HYDROCORTISONE | TABLET;ORAL | 20MG | Discontinued | |||
| HYDROCORTONE | HYDROCORTISONE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA008472 - MERCK | |||||||
| CYCLAINE | HEXYLCAINE HYDROCHLORIDE | SOLUTION;TOPICAL | 5% | Discontinued | |||
| NDA008228 - MERCK | |||||||
| HYDROCORTONE | HYDROCORTISONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| HYDROCORTONE | HYDROCORTISONE ACETATE | INJECTABLE;INJECTION | 50MG/ML | Discontinued | |||
| NDA008114 - SCHERING | |||||||
| PRANTAL | DIPHEMANIL METHYLSULFATE | TABLET;ORAL | 100MG | Discontinued | |||
| NDA007898 - MERCK | |||||||
| BENEMID | PROBENECID | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA007750 - MERCK | |||||||
| CORTONE | CORTISONE ACETATE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA007110 - MERCK | |||||||
| CORTONE | CORTISONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | Discontinued | |||
| CORTONE | CORTISONE ACETATE | INJECTABLE;INJECTION | 50MG/ML | Discontinued | |||
| NDA006921 - SCHERING | |||||||
| CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | TABLET;ORAL | 4MG | Discontinued | |||
| CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | SYRUP;ORAL | 2MG/5ML | Discontinued | |||
| NDA006668 - MERCK | |||||||
| REDISOL | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
| NDA005963 - SCHERING | |||||||
| SODIUM SULAMYD | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SODIUM SULAMYD | SULFACETAMIDE SODIUM | OINTMENT;OPHTHALMIC | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| SODIUM SULAMYD | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
| NDA005620 - MERCK | |||||||
| MANNITOL 25% | MANNITOL | INJECTABLE;INJECTION | 12.5GM/50ML | Discontinued | |||
| NDA005619 - MERCK | |||||||
| AMINOHIPPURATE SODIUM | AMINOHIPPURATE SODIUM | INJECTABLE;INJECTION | 20% | Discontinued | |||
| NDA005292 - SCHERING | |||||||
| ESTINYL | ETHINYL ESTRADIOL | TABLET;ORAL | 0.05MG | Discontinued | |||
| ESTINYL | ETHINYL ESTRADIOL | TABLET;ORAL | 0.02MG | Discontinued | |||
| ESTINYL | ETHINYL ESTRADIOL | TABLET;ORAL | 0.5MG | Discontinued | |||
| NDA003158 - SCHERING | |||||||
| ORETON METHYL | METHYLTESTOSTERONE | TABLET;ORAL | 25MG | Discontinued | |||
| ORETON METHYL | METHYLTESTOSTERONE | TABLET;ORAL | 10MG | Discontinued | |||
| NDA001546 - MERCK SHARP DOHME | |||||||
| GUANIDINE HYDROCHLORIDE | GUANIDINE HYDROCHLORIDE | TABLET;ORAL | 125MG | Discontinued | |||