FDA.report

Application 091634

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ALYACEN 1/35ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;1MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1477ALYACEN 1/35norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-1477ALYACEN 1/35norethindrone and ethinyl estradiolA-S Medication SolutionsANDACurrent
53002-1780ALYACEN 1/35norethindrone and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-394ALYACEN 1/35norethindrone and ethinyl estradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
70518-1212ALYACEN 1/35norethindrone and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
71205-547ALYACEN 1/35norethindrone and ethinyl estradiolProficient Rx LPANDACurrent