← FDA DRUG APPROVALS

FDA NDA · NDA016608

TEGRETOL

carbamazepine

Sponsor: NOVARTIS

APPLICATION
NDA016608
TYPE
NDA
ORIGINAL APPROVAL
1968-03-11
LATEST ACTION
2026-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TEGRETOL · ReferencePrescription
CARBAMAZEPINE 200MG · TABLET · ORAL

Approval history

2026-07-15Labeling · Supplement 124 · standard — Letter ↗AP
2025-09-30Labeling · Supplement 122 · standard — Label ↗AP
2023-09-13Labeling · Supplement 121 · standard — Letter ↗AP
2018-03-20Labeling · Supplement 116 · standard — Letter ↗AP
2015-10-30Manufacturing (CMC) · Supplement 111 · priorityAP
2015-08-28Labeling · Supplement 97 · standard — Label ↗AP
2014-09-16Labeling · Supplement 99 · standard — Letter ↗AP
2014-01-16Labeling · Supplement 103 · unknown — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 108 · priorityAP
2013-03-06Labeling · Supplement 105 · standard — Letter ↗AP
2012-12-11Labeling · Supplement 107 · standard — Letter ↗AP
2011-10-30REMS · Supplement 106 — Letter ↗AP
2011-03-03Labeling · Supplement 102 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 100 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 101 · 901 required — Letter ↗AP
2007-12-11Labeling · Supplement 98 · standard — Other ↗AP
2007-08-16Labeling · Supplement 96 · standard — Letter ↗AP
2002-01-28Manufacturing (CMC) · Supplement 94 · priorityAP
2001-11-19Manufacturing (CMC) · Supplement 92 · priorityAP
2001-11-15Manufacturing (CMC) · Supplement 93 · priorityAP
2001-03-07Labeling · Supplement 90 · standard — Review ↗AP
2000-05-18Manufacturing (CMC) · Supplement 91 · priorityAP
2000-04-11Manufacturing (CMC) · Supplement 89 · priorityAP
2000-04-10Labeling · Supplement 88 · standardAP
2000-04-10Labeling · Supplement 84 · standardAP
1999-06-07Manufacturing (CMC) · Supplement 87 · priorityAP
1999-04-21Manufacturing (CMC) · Supplement 86 · priorityAP
1998-07-15Labeling · Supplement 80 · standardAP
1998-07-15Labeling · Supplement 85 · standardAP
1998-07-15Labeling · Supplement 83 · standardAP
1998-07-15Labeling · Supplement 81 · standardAP
1997-03-06Manufacturing (CMC) · Supplement 82 · priorityAP
1995-10-11Efficacy · Supplement 59AP
1995-10-05Manufacturing (CMC) · Supplement 79 · priorityAP
1993-10-06Manufacturing (CMC) · Supplement 77 · priorityAP
1991-03-14Manufacturing (CMC) · Supplement 71 · priorityAP
1990-06-01Manufacturing (CMC) · Supplement 70 · priorityAP
1990-03-28Manufacturing (CMC) · Supplement 66 · priorityAP
1990-03-28Manufacturing (CMC) · Supplement 65 · priorityAP
1990-03-27Manufacturing (CMC) · Supplement 64 · priorityAP
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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