← FDA DRUG APPROVALS

FDA NDA · NDA020712

CARBATROL

carbamazepine

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA020712
TYPE
NDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2023-04-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CARBATROL · ReferencePrescription
CARBAMAZEPINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBATROL · ReferencePrescription
CARBAMAZEPINE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
CARBATROL · ReferencePrescription
CARBAMAZEPINE 300MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-04-11Labeling · Supplement 38 · standard — Label ↗AP
2021-12-01Labeling · Supplement 37 · standard — Letter ↗AP
2018-08-26Labeling · Supplement 36 · standard — Label ↗AP
2013-03-22Labeling · Supplement 32 · standard — Label ↗AP
2013-03-22Labeling · Supplement 35 · unknown — Letter ↗AP
2011-08-22REMS · Supplement 34 — Letter ↗AP
2011-01-26Labeling · Supplement 31 · standard — Label ↗AP
2009-04-23Labeling · Supplement 30 · 901 required — Label ↗AP
2007-12-11Labeling · Supplement 29 · standard — Label ↗AP
2006-06-30Labeling · Supplement 25 · standard — Label ↗AP
2006-01-24Labeling · Supplement 24 · standard — Letter ↗AP
2002-08-07Manufacturing (CMC) · Supplement 16 · standardAP
2002-02-21Manufacturing (CMC) · Supplement 15 · standardAP
2001-10-30Manufacturing (CMC) · Supplement 14 · standardAP
2001-05-17Manufacturing (CMC) · Supplement 11 · standardAP
2000-08-08Manufacturing (CMC) · Supplement 13 · standardAP
2000-08-08Manufacturing (CMC) · Supplement 12 · standardAP
2000-06-14Manufacturing (CMC) · Supplement 10 · standardAP
2000-01-19Manufacturing (CMC) · Supplement 9 · standardAP
1999-12-22Manufacturing (CMC) · Supplement 7 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 8 · standardAP
1999-06-28Manufacturing (CMC) · Supplement 6 · standardAP
1999-06-28Manufacturing (CMC) · Supplement 5 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 2 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 3 · standardAP
1998-07-24Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-30Type 3 - New Dosage Form · Original · standard — Review ↗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 →