FDA.reportPublic FDA data

Application 203865

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1551Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1551Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1551Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1551Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals LLCANDACurrent