FDA.reportPublic FDA data

Application 076561

Type
ANDA
Sponsor
AMICI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL50MGNoNo
002CATAFLAMDICLOFENAC POTASSIUMTABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15370-180LOFENADICLOFENAC POTASSIUMCARWIN PHARMACEUTICAL ASSOCIATES, LLCANDACurrent
51407-443Diclofenac Potassiumdiclofenac potassiumGolden State Medical Supply, Inc.ANDACurrent
69292-550Diclofenac Potassiumdiclofenac potassiumAmici Pharmaceuticals LLC.ANDACurrent
69292-550Diclofenac Potassiumdiclofenac potassiumAmici Pharmaceuticals LLC.ANDACurrent
69292-550Diclofenac Potassiumdiclofenac potassiumAmici Pharmaceuticals LLC.ANDACurrent
69292-550Diclofenac Potassiumdiclofenac potassiumAmici Pharmaceuticals LLC.ANDACurrent
70934-906Diclofenac Potassiumdiclofenac potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
73684-150CATAFLAMdiclofenac potassiumBLUCREST PHARMACEUTICALS, LLCANDACurrent
73684-150CATAFLAMdiclofenac potassiumBLUCREST PHARMACEUTICALS, LLCANDACurrent