FDA.reportPublic FDA data

Application 077681

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-545SRONYXLevonorgestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-545SRONYXLevonorgestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
53002-1539SRONYXLevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1539SRONYXLevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44535ORIG2014-03-20
39539ORIG2014-03-20