FDA.reportPublic FDA data

Application 203995

Type
ANDA
Sponsor
AMNEAL PHARMS

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
50090-4618Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolA-S Medication SolutionsANDACurrent
50090-4618Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolA-S Medication SolutionsANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-436Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
65162-438Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLCANDACurrent
68788-7103Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7103Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7103Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals Inc.ANDACurrent
71335-1183Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
71335-1183Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent