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FDA ANDA · ANDA206597

HAILEY FE 1/20

norethindrone acetate and ethinyl estradiol and ferrous fumarate

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA206597
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-21
LATEST ACTION
2025-06-17
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HAILEY FE 1/20Prescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-28

Approval history

2025-06-17Labeling · Supplement 4 · standardAP
2025-06-17Labeling · Supplement 5 · standardAP
2017-11-21UNKNOWN · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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