FDA.reportPublic FDA data

Application 091234

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOGESTREL AND ETHINYL ESTRADIOLDESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-464JuleberDesogestrel and Ethinyl EstradiolNorthstar Rx LLCANDACurrent
16714-464JuleberDesogestrel and Ethinyl EstradiolNorthstar Rx LLCANDACurrent
51862-514Desogestrel and Ethinyl EstradiolDesogestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-514Desogestrel and Ethinyl EstradiolDesogestrel and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent