FDA.reportPublic FDA data

Application 205588

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-838Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-838Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-838Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-838Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-838Norgestimate and ethinyl estradiolNorgestimate and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent