← FDA DRUG APPROVALS

FDA NDA · NDA020234

TEGRETOL XR

carbamazepine

Sponsor: NOVARTIS

APPLICATION
NDA020234
TYPE
NDA
ORIGINAL APPROVAL
1996-03-25
LATEST ACTION
2026-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TEGRETOL-XR · ReferencePrescription
CARBAMAZEPINE 200MG · TABLET, EXTENDED RELEASE · ORAL
TEGRETOL-XR · ReferencePrescription
CARBAMAZEPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
TEGRETOL-XR · ReferencePrescription
CARBAMAZEPINE 100MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-15Labeling · Supplement 57 · standard — Letter ↗AP
2025-09-30Labeling · Supplement 55 · standard — Label ↗AP
2023-09-13Labeling · Supplement 54 · standard — Letter ↗AP
2018-03-20Labeling · Supplement 47 · standard — Letter ↗AP
2015-08-28Labeling · Supplement 26 · standard — Label ↗AP
2014-09-16Labeling · Supplement 30 · standard — Letter ↗AP
2014-01-16Labeling · Supplement 35 · unknown — Letter ↗AP
2013-07-29Manufacturing (CMC) · Supplement 41 · standardAP
2013-03-06Labeling · Supplement 38 · standard — Letter ↗AP
2012-12-11Labeling · Supplement 40 · standard — Label ↗AP
2011-10-30REMS · Supplement 39 — Letter ↗AP
2011-03-03Labeling · Supplement 33 · standard — Label ↗AP
2011-03-03Labeling · Supplement 31 · standard — Label ↗AP
2009-04-23Labeling · Supplement 32 · 901 required — Letter ↗AP
2007-12-11Labeling · Supplement 28 · standard — Label ↗AP
2007-08-16Labeling · Supplement 25 · standard — Label ↗AP
2002-05-06Manufacturing (CMC) · Supplement 21 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 22 · standardAP
2001-11-15Manufacturing (CMC) · Supplement 20 · standardAP
2001-03-07Labeling · Supplement 17 · standard — Review ↗AP
2001-02-22Manufacturing (CMC) · Supplement 19 · standardAP
2001-01-11Manufacturing (CMC) · Supplement 18 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 16 · standardAP
2000-04-10Labeling · Supplement 7 · standardAP
2000-04-10Labeling · Supplement 14 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-14Manufacturing (CMC) · Supplement 13 · standardAP
1999-06-29Manufacturing (CMC) · Supplement 12 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 11 · standardAP
1999-01-04Manufacturing (CMC) · Supplement 10 · standardAP
1998-09-17Manufacturing (CMC) · Supplement 9 · standardAP
1998-07-15Labeling · Supplement 5 · standardAP
1998-07-15Labeling · Supplement 8 · standardAP
1998-07-15Labeling · Supplement 6 · standardAP
1998-07-15Labeling · Supplement 2 · standardAP
1996-09-24Manufacturing (CMC) · Supplement 3 · standardAP
1996-07-26Manufacturing (CMC) · Supplement 4 · standardAP
1996-06-24Manufacturing (CMC) · Supplement 1 · standardAP
1996-03-25Type 3 - New Dosage Form · Original · standard — Review ↗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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