← FDA DRUG APPROVALS

FDA NDA · NDA218718

FEMLYV

norethindrone acetate/ethinyl estradiol

Sponsor: MILLICENT MFG PR

APPLICATION
NDA218718
TYPE
NDA
ORIGINAL APPROVAL
2024-07-22
LATEST ACTION
2025-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

FEMLYV · ReferencePrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-07-29Labeling · Supplement 1 · standard — Label ↗AP
2024-07-22Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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