FDA.reportPublic FDA data

Application 202015

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YAELADROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL-283MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75834-115Drospirenone and Ethinyl EstradiolDrospirenone and Ethinyl EstradiolNivagen Pharmaceuticals, Inc.ANDACurrent
75834-115Drospirenone and Ethinyl EstradiolDrospirenone and Ethinyl EstradiolNivagen Pharmaceuticals, Inc.ANDACurrent