FDA.reportPublic FDA data

Application 201661

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIKKIDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL3MG;0.02MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-886Nikkidrospirenone and ethinyl estradiolLUPIN LIMITEDANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, InANDACurrent
68180-886Nikkidrospirenone and ethinyl estradiolLupin Pharmaceuticals, Inc.ANDACurrent