FDA.reportPublic FDA data

Application 200538

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2259Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2259Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2259Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-2259Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50090-3394Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
53002-1732Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1732Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
68462-309Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-309Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-309Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-309Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-309Norgestimate and Ethinyl EstradiolNorgestimate and Ethinyl EstradiolGlenmark Pharmaceuticals Inc., USAANDACurrent