FDA.reportPublic FDA data

Application 090081

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-036ZarahDrospirenone and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-036ZarahDrospirenone and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
52544-981ZarahDrospirenone and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
53002-1627ZarahDrospirenone and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1627ZarahDrospirenone and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31449ORIG2010-03-22