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FDA ANDA · ANDA204847

HAILEY 24 FE

norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA204847
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-17
LATEST ACTION
2023-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HAILEY 24 FEPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2023-08-07Labeling · Supplement 6 · standardAP
2023-08-07Labeling · Supplement 7 · standardAP
2022-04-29Labeling · Supplement 4 · standardAP
2022-02-07Labeling · Supplement 3 · standardAP
2017-11-17UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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