FDA.reportPublic FDA data

Application 091425

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLUPIN LIMITEDANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-854Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
76413-111Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolCentral Texas Community Health CentersANDACurrent