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Hailey Fe 1.5/30

Hailey Fe 1.5/30(Each light green to green tablet contains 1.5 mg norethindrone acetate, USP and 30 mcg ethinyl estradiol, USP. Each brown to dark brown tablet contains 75 mg ferrous fumarate, USP).

Approved
Approval ID

e3f602d6-b863-4e7e-8494-c0aa25d0e5b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 11, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

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 Code53002-1812
Application NumberANDA209031
Marketing CategoryC73584
Route of AdministrationN/A
Effective DateFebruary 21, 2023
Generic NameNorethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

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Hailey Fe 1.5/30 - FDA Drug Approval Details