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FDA NDA · NDA022526

ADDYI

flibanserin

Sponsor: SPROUT PHARMS

APPLICATION
NDA022526
TYPE
NDA
ORIGINAL APPROVAL
2015-08-18
LATEST ACTION
2025-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ADDYI · ReferencePrescription
FLIBANSERIN 100MG · TABLET · ORAL

Approval history

2025-12-13Efficacy · Supplement 13 · priority — Letter ↗AP
2025-01-21REMS · Supplement 12 — Letter ↗AP
2021-09-29Labeling · Supplement 10 · standard — Letter ↗AP
2019-10-09REMS · Supplement 9 — Label ↗AP
2019-10-09Labeling · Supplement 8 · standard — Letter ↗AP
2019-04-11Supplement · Supplement 6 · unknown — Letter ↗AP
2019-04-02REMS · Supplement 7 — Letter ↗AP
2017-06-16REMS · Supplement 4 — Letter ↗AP
2016-04-08REMS · Supplement 2 — Letter ↗AP
2015-08-18Type 1 - New Molecular Entity · Original · standard — Label ↗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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