FDA.reportPublic FDA data

Application 210079

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1327Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1327Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1327Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1328Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1328Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1328Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1329Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1329Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1329Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1330Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1330Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1330Oxycodone and AcetaminophenOxycodone and AcetaminophenZydus Pharmaceuticals (USA) Inc.ANDACurrent