FDA.reportPublic FDA data

Application 073594

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVORA 0.15/30-28ETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-260LevoraLevonorgestrel and Ethinyl EstradiolRebel Distributors CorpANDACurrent
51862-097Levoralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-097Levoralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-097Levoralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-097Levoralevonorgestrel and ethinyl estradiolMayne Pharma Inc.ANDACurrent
53002-1565Levoralevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1565Levoralevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent