FDA.reportPublic FDA data

Application 215750

Type
ANDA
Sponsor
UMEDICA LABS PVT LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60290-057Diclofenac PotassiumDiclofenac Potassium TabletsUMEDICA LABORATORIES PRIVATE LIMITEDANDACurrent
60290-057Diclofenac PotassiumDiclofenac Potassium TabletsUMEDICA LABORATORIES PRIVATE LIMITEDANDACurrent
70710-1832Diclofenac PotassiumDiclofenac Potassium TabletsZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1832Diclofenac PotassiumDiclofenac Potassium TabletsZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1832Diclofenac PotassiumDiclofenac Potassium TabletsZydus Pharmaceuticals (USA) Inc.ANDACurrent