FDA.reportPublic FDA data

Application 091408

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KURVELOETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-844KurveloLevonorgestrel and Ethinyl EstradiolLUPIN LIMITEDANDACurrent
57297-844KurveloLevonorgestrel and Ethinyl EstradiolLUPIN LIMITEDANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844Kurvelolevonorgestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-844KurveloLevonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.ANDACurrent