FDA.reportPublic FDA data

Application 202016

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75834-116Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-116Drospirenone and ethinyl estradiolDrospirenone and ethinyl estradiolNivagen Pharmaceuticals, Inc.ANDACurrent