FDA.reportPublic FDA data

Application 202226

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEKYREEDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG,N/A;0.02MG,0.01MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-880Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLUPIN LIMITEDANDACurrent
68180-879Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-879Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-879Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-879Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-879Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-880Bekyreedesogestrel and ethinyl estradiol and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent