← FDA DRUG APPROVALS

FDA NDA · NDA018927

TEGRETOL

carbamazepine

Sponsor: NOVARTIS

APPLICATION
NDA018927
TYPE
NDA
ORIGINAL APPROVAL
1987-12-18
LATEST ACTION
2026-07-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

TEGRETOL · ReferencePrescription
CARBAMAZEPINE 100MG/5ML · SUSPENSION · ORAL

Approval history

2026-07-15Labeling · Supplement 63 · standard — Letter ↗AP
2025-09-30Labeling · Supplement 61 · standard — Label ↗AP
2023-09-13Labeling · Supplement 60 · standard — Letter ↗AP
2018-03-20Labeling · Supplement 55 · standard — Letter ↗AP
2016-07-08Manufacturing (CMC) · Supplement 52 · standardAP
2016-06-17Manufacturing (CMC) · Supplement 51 · standardAP
2015-08-28Labeling · Supplement 38 · standard — Letter ↗AP
2014-09-16Labeling · Supplement 40 · standard — Letter ↗AP
2014-01-16Labeling · Supplement 44 · unknown — Letter ↗AP
2013-11-08Manufacturing (CMC) · Supplement 49 · standardAP
2013-03-06Labeling · Supplement 46 · standard — Letter ↗AP
2012-12-11Labeling · Supplement 48 · standard — Label ↗AP
2011-10-30REMS · Supplement 47 — Letter ↗AP
2011-03-03Labeling · Supplement 41 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 42 · standard — Label ↗AP
2009-04-23Labeling · Supplement 43 · 901 required — Label ↗AP
2007-12-11Labeling · Supplement 39 · standard — Letter ↗AP
2007-08-16Labeling · Supplement 35 · standard — Label ↗AP
2002-12-11Manufacturing (CMC) · Supplement 34 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 33 · standardAP
2001-11-15Manufacturing (CMC) · Supplement 32 · standardAP
2001-03-07Labeling · Supplement 31 · standard — Label ↗AP
2000-04-11Manufacturing (CMC) · Supplement 30 · standardAP
2000-04-10Labeling · Supplement 28 · standardAP
2000-04-10Labeling · Supplement 24 · standardAP
2000-03-08Manufacturing (CMC) · Supplement 29 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 26 · standardAP
1998-12-29Manufacturing (CMC) · Supplement 27 · standardAP
1998-07-15Labeling · Supplement 25 · standardAP
1998-07-15Labeling · Supplement 23 · standardAP
1998-07-15Labeling · Supplement 21 · standardAP
1998-07-15Labeling · Supplement 20 · standardAP
1997-01-02Manufacturing (CMC) · Supplement 22 · standardAP
1995-10-11Efficacy · Supplement 18 · standardAP
1995-08-09Manufacturing (CMC) · Supplement 19 · standardAP
1993-10-06Manufacturing (CMC) · Supplement 16 · standardAP
1991-03-14Manufacturing (CMC) · Supplement 10 · standardAP
1990-03-26Labeling · Supplement 8AP
1989-08-01Manufacturing (CMC) · Supplement 6 · standardAP
1989-07-21Labeling · Supplement 5AP
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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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