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TAYSOFY

These highlights do not include all the information needed to use TAYSOFY safely and effectively. See full prescribing information for . norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), for oral use Initial U.S. Approval: 1968

Approved
Approval ID

5b7b33cf-7b58-4ba2-b819-9cd4602edc8b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 3, 2022

Manufacturers
FDA

Amneal Pharmaceuticals 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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65162-558
Application NumberANDA214292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification

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TAYSOFY - FDA Drug Approval Details