FDA.reportPublic FDA data

Application 200540

Type
ANDA
Sponsor
EXELA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL50MG;0.2MGNoNo
002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL75MG;0.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-955Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBlenheim Pharmacal, Inc.ANDACurrent
42367-110Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolEagle Pharmaceuticals, Inc.ANDACurrent
42367-111Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolEagle Pharmaceuticals, Inc.ANDACurrent
69339-123Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolDash Pharmaceuticals LLCANDACurrent
69339-124Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolDash Pharmaceuticals LLCANDACurrent