FDA.reportPublic FDA data

Application 091247

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIMTREADESOGESTREL; ETHINYL ESTRADIOLTABLET;ORAL-280.15MG,N/A;0.02MG,0.01MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-404PIMTREAdesogestrel/ethinyl estradiol and ethinyl estradiolNorthstar Rx LLCANDACurrent
51862-890Azurettedesogestrel/ethinyl estradiol and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-890Azurettedesogestrel/ethinyl estradiol and ethinyl estradiolMayne Pharma Inc.ANDACurrent