FDA.reportPublic FDA data

Application 076785

Type
ANDA
Sponsor
BARR

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9064Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9064Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9064Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9064Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9064Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-2191Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2191Kelnor 1/35Ethynodiol Diacetate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
51862-260Zovia 1/35Ethynodiol Diacetate and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-260Zovia 1/35Ethynodiol Diacetate and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-260Zovia 1/35Ethynodiol Diacetate and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
53002-1591Zovia 1/35Ethynodiol Diacetate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1591Zovia 1/35Ethynodiol Diacetate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent