FDA.reportPublic FDA data

Application 208578

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 30MG BASENoNo
002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 45MG BASENoNo
003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3718OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEA-S Medication SolutionsANDACurrent
50090-3718OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEA-S Medication SolutionsANDACurrent
50090-3718OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEA-S Medication SolutionsANDACurrent
53002-1387OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
53002-1387OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
53002-1710OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
53002-1710OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
68071-3385OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7070OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.ANDACurrent
70518-0764OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEREMEDYREPACK INC.ANDACurrent
70518-0764OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEREMEDYREPACK INC.ANDACurrent
70710-1008OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1008OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1008OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1008OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1008OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1009OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1009OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1009OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1009OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1009OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1010OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1010OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1010OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1010OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1010OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1710OSELTAMIVIR PHOSPHATEoseltamivir phosphateCadila Healthcare LimitedANDACurrent
70771-1710OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Lifesciences LimitedANDACurrent
70771-1711OSELTAMIVIR PHOSPHATEoseltamivir phosphateCadila Healthcare LimitedANDACurrent
70771-1711OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Lifesciences LimitedANDACurrent
70771-1712OSELTAMIVIR PHOSPHATEoseltamivir phosphateCadila Healthcare LimitedANDACurrent
70771-1712OSELTAMIVIR PHOSPHATEoseltamivir phosphateZydus Lifesciences LimitedANDACurrent