← FDA DRUG APPROVALS

FDA NDA · NDA010841

PEGANONE

Sponsor: RECORDATI RARE

APPLICATION
NDA010841
TYPE
NDA
ORIGINAL APPROVAL
1957-04-22
LATEST ACTION
2017-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PEGANONEDiscontinued
ETHOTOIN 500MG · TABLET · ORAL
PEGANONE · ReferenceDiscontinued
ETHOTOIN 250MG · TABLET · ORAL

Approval history

2017-02-27Manufacturing (CMC) · Supplement 25AP
2013-01-23Manufacturing (CMC) · Supplement 24 · priorityAP
2011-05-31REMS · Supplement 23 — Letter ↗AP
2010-06-07Labeling · Supplement 22 · standard — Medication Guide ↗AP
2009-04-23Labeling · Supplement 21 · 901 required — Label ↗AP
2007-02-02Labeling · Supplement 20 · standard — Letter ↗AP
2003-09-26Labeling · Supplement 13 — Letter ↗AP
2003-09-26Labeling · Supplement 14 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 17 · priorityAP
2002-04-04Manufacturing (CMC) · Supplement 16 · priorityAP
1998-05-13Manufacturing (CMC) · Supplement 15 · priorityAP
1984-11-13Manufacturing (CMC) · Supplement 12 · priorityAP
1983-10-28Manufacturing (CMC) · Supplement 11 · priorityAP
1982-11-04Manufacturing (CMC) · Supplement 10 · priorityAP
1982-07-12Manufacturing (CMC) · Supplement 9 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 5 · priorityAP
1957-04-22Type 1 - New Molecular Entity · Original · priorityAP
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 →