FDA.reportPublic FDA data

Application 078833

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL3MG;0.02MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4000VesturaDrospirenone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4000VesturaDrospirenone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
52544-982VesturaDrospirenone and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent