FDA.reportPublic FDA data

Application 203339

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMABELZESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL0.5MG;0.1MGNoNo
002AMABELZESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL1MG;0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-829AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent
68180-830AMABELZestradiol and norethindrone acetateLupin Pharmaceuticals, Inc.ANDACurrent