FDA.reportPublic FDA data

Application 200248

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLUPIN LIMITEDANDACurrent
68180-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-857Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent