FDA.reportPublic FDA data

Application 201887

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENSKYCEDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-882ENSKYCEdesogestrel and ethinyl estradiolLUPIN LIMITEDANDACurrent
68180-882ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-882ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-882ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-891ENSKYCEdesogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent