FDA.reportPublic FDA data

Application 205947

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUMDROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUMTABLET;ORAL3MG,N/A;0.02MG,N/A;0.451MG,0.451MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-894DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-894DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-894DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-894DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-894drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumdrospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-894DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.ANDACurrent