← FDA DRUG APPROVALS

FDA NDA · NDA203505

OSPHENA

ospemifene

Sponsor: DUCHESNAY

APPLICATION
NDA203505
TYPE
NDA
ORIGINAL APPROVAL
2013-02-26
LATEST ACTION
2025-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OSPHENA · ReferencePrescription
OSPEMIFENE 60MG · TABLET · ORAL

Approval history

2025-02-07Labeling · Supplement 18 · standard — Letter ↗AP
2024-02-15Labeling · Supplement 22 · standard — Letter ↗AP
2019-01-25Efficacy · Supplement 15 · standard — Label ↗AP
2018-10-26Labeling · Supplement 14 · standard — Letter ↗AP
2017-03-17Manufacturing (CMC) · Supplement 12AP
2016-11-03Manufacturing (CMC) · Supplement 11 · standardAP
2015-08-24Manufacturing (CMC) · Supplement 9 · standardAP
2015-08-24Manufacturing (CMC) · Supplement 10 · standardAP
2015-08-24Manufacturing (CMC) · Supplement 8 · standardAP
2015-04-23Manufacturing (CMC) · Supplement 6 · standardAP
2015-04-20Manufacturing (CMC) · Supplement 7 · standardAP
2015-02-25Labeling · Supplement 5 · standard — Label ↗AP
2014-05-02Manufacturing (CMC) · Supplement 4 · standardAP
2014-01-08Manufacturing (CMC) · Supplement 3 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 2 · standardAP
2013-08-13Manufacturing (CMC) · Supplement 1 · standardAP
2013-02-26Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →