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FDA ANDA · ANDA202994

MICROGESTIN 24 FE

norethindrone acetate/ethinyl estradiol and ferrous fumarate

Sponsor: NOVAST LABS

APPLICATION
ANDA202994
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-18
LATEST ACTION
2025-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-06-16Labeling · Supplement 11 · standardAP
2022-04-29Labeling · Supplement 10 · standardAP
2022-03-03Labeling · Supplement 2 · standardAP
2022-03-03Labeling · Supplement 9 · standardAP
2015-02-18UNKNOWN · OriginalAP
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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