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Nexesta Fe

These highlights do not include all the information needed to use NEXESTA Fe safely and effectively. See Full Prescribing Information for NEXESTA Fe. NEXESTA Fe (norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable)) for oral use Initial U.S. Approval: 1975

Approved
Approval ID

6eb8f7b6-4b8e-4bad-800a-b2f3b36c3413

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 2021

Manufacturers
FDA

Aurobindo Pharma Limited

DUNS: 650082092

Products 1

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

norethindrone and ethinyl estradiol and ferrous fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65862-926
Application NumberANDA207535
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone and ethinyl estradiol and ferrous fumarate
Product Specifications
Effective DateDecember 4, 2021
FDA Product Classification

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Nexesta Fe - FDA Drug Approval Details