FDA.reportPublic FDA data

Application 091674

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG,0.1MG;0.01MG,N/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-848Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiollevonorgestrel and ethinyl estradiolLUPIN LIMITEDANDACurrent
68180-848Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiollevonorgestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-848Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiollevonorgestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-848Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiollevonorgestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent