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Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablets and ferrous fumarate tablets, for oral use Initial U.S. Approval: 1968

Approved
Approval ID

d4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 18, 2023

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

PRODUCT DETAILS

NDC Product Code60219-1031
Application NumberANDA207514
Marketing CategoryC73584
Route of AdministrationN/A
Effective DateJuly 6, 2023
Generic NameNorethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

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Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate - FDA Drug Approval Details