← FDA DRUG APPROVALS

FDA NDA · NDA020687

MIFEPREX

Sponsor: DANCO LABS LLC

APPLICATION
NDA020687
TYPE
NDA
ORIGINAL APPROVAL
2000-09-28
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MIFEPREX · ReferencePrescription
MIFEPRISTONE 200MG · TABLET · ORAL

Approval history

2025-09-30REMS · Supplement 27 — Letter ↗AP
2023-03-23REMS · Supplement 26 — Letter ↗AP
2023-01-03REMS · Supplement 25 — Letter ↗AP
2021-05-14REMS · Supplement 24 — Letter ↗AP
2019-04-11REMS · Supplement 22 — Label ↗AP
2016-08-05Manufacturing (CMC) · Supplement 23 · standardAP
2016-03-29Efficacy · Supplement 20 · standard — Review ↗AP
2016-03-10Manufacturing (CMC) · Supplement 21 · priorityAP
2013-03-26Manufacturing (CMC) · Supplement 19 · priorityAP
2011-06-08Labeling · Supplement 14 · standard — Other ↗AP
2009-04-24Labeling · Supplement 15 · standard — Letter ↗AP
2005-07-19Labeling · Supplement 13 · standard — Label ↗AP
2004-12-22Labeling · Supplement 11 · standard — Letter ↗AP
2004-11-15Labeling · Supplement 10 · standard — Letter ↗AP
2002-03-29Manufacturing (CMC) · Supplement 1 · priorityAP
2000-09-28Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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