FDA.reportPublic FDA data

Application 203870

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3239Tri Femynornorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-3239Tri Femynornorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-3239Tri Femynornorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-3413Tri Femynornorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-3413Tri Femynornorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
69238-1607Tri Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1607Tri Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1607Tri Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1607Tri Femynornorgestimate and ethinyl estradiolAmneal Pharmaceuticals NY LLCANDACurrent