FDA.report

Application 200494

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo
002NORGESTIMATE; ETHINYL ESTRADIOLNORGESTIMATE; ETHINYL ESTRADIOLTABLET; ORAL0.215MG; 0.035MGNoNo
003NORGESTIMATE; ETHINYL ESTRADIOLNORGESTIMATE; ETHINYL ESTRADIOLTABLET; ORAL0.25MG; 0.035MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2603Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-1733Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1733Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-565Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-7302Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7894Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals IncANDACurrent
68788-7894Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolPreferred Pharmaceuticals IncANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent
71205-191Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolProficient Rx LPANDACurrent