FDA.reportPublic FDA data

Application 209548

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LO-MALMOREDEETHINYL ESTRADIOL; ETHYNODIOL DIACETATETABLET;ORAL-280.035MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-894Zovia 1/35Ethynodiol Diacetate and Ethinyl Estradiol TabletsMayne Pharma Inc.ANDACurrent
51862-894Zovia 1/35Ethynodiol Diacetate and Ethinyl Estradiol TabletsMayne Pharma Inc.ANDACurrent