FDA.reportPublic FDA data

Application 212706

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MERZEEETHINYL ESTRADIOL; NORETHINDRONE ACETATECAPSULE;ORAL0.02MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-371MERZEENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
43386-371MERZEENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
43386-371MERZEENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
71225-130MERZEENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATESlayback Pharma LLCANDACurrent
71225-130MERZEENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATESlayback Pharma LLCANDACurrent