FDA.reportPublic FDA data

Application 071268

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-2739IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2756IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2756IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2759IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2789IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2789IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2789IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2789IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2797IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2798IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8201IbuprofenIbuprofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-8244IbuprofenIbuprofenPreferred Pharmaceuticals Inc.ANDACurrent
71921-180IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent
71921-180IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent
71921-181IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent
71921-181IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent
71921-182IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent
71921-182IbuprofenIbuprofenFlorida Pharmaceutical Products, LLCANDACurrent