FDA.report

Application 091636

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ALYACEN 7/7/7ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo
002ALYACEN 777NORETHINDRONE; ETHINYL ESTRADIOLTABLET; ORAL0.75MG; 0.035MGNoNo
003ALYACEN 777NORETHINDRONE; ETHINYL ESTRADIOLTABLET; ORAL1MG; 0.035MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1478ALYACEN 7/7/7norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
53002-1734ALYACEN 7/7/7norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1734ALYACEN 7/7/7norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-556ALYACEN 7/7/7norethindrone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent