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FDA NDA · NDA018281

TEGRETOL

Sponsor: NOVARTIS

APPLICATION
NDA018281
TYPE
NDA
ORIGINAL APPROVAL
1981-12-14
LATEST ACTION
2018-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

TEGRETOL · ReferenceDiscontinued
CARBAMAZEPINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2018-03-20Labeling · Supplement 58 · standard — Letter ↗AP
2015-08-28Labeling · Supplement 45 · standard — Letter ↗AP
2014-09-16Labeling · Supplement 47 · standard — Letter ↗AP
2014-01-16Labeling · Supplement 51 · unknown — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 56 · standardAP
2013-03-06Labeling · Supplement 53 · standard — Label ↗AP
2012-12-11Labeling · Supplement 55 · standard — Label ↗AP
2011-10-30REMS · Supplement 54AP
2011-03-03Labeling · Supplement 49 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 50 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 48 · 901 required — Label ↗AP
2007-12-11Labeling · Supplement 46 · standard — Label ↗AP
2007-08-16Labeling · Supplement 44 · standard — Label ↗AP
2002-03-05Manufacturing (CMC) · Supplement 43 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 42 · standardAP
2001-11-15Manufacturing (CMC) · Supplement 41 · standardAP
2001-03-07Labeling · Supplement 39 · standard — Review ↗AP
2000-05-18Manufacturing (CMC) · Supplement 40 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 38 · standardAP
2000-04-10Labeling · Supplement 37 · standardAP
2000-04-10Labeling · Supplement 33 · standardAP
1999-04-23Manufacturing (CMC) · Supplement 36 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 35 · standardAP
1998-07-15Labeling · Supplement 31 · standard — Review ↗AP
1998-07-15Labeling · Supplement 34 · standardAP
1998-07-15Labeling · Supplement 32 · standardAP
1998-07-15Labeling · Supplement 30 · standardAP
1995-10-11Efficacy · Supplement 10AP
1995-02-03Manufacturing (CMC) · Supplement 20 · standardAP
1993-10-06Manufacturing (CMC) · Supplement 28 · standardAP
1992-11-23Manufacturing (CMC) · Supplement 21 · standardAP
1991-03-14Manufacturing (CMC) · Supplement 22 · standardAP
1990-03-29Manufacturing (CMC) · Supplement 15 · standardAP
1990-03-29Manufacturing (CMC) · Supplement 16 · standardAP
1990-03-27Manufacturing (CMC) · Supplement 14 · standardAP
1990-03-26Labeling · Supplement 18AP
1989-07-21Labeling · Supplement 13AP
1989-04-07Manufacturing (CMC) · Supplement 12 · standardAP
1988-08-01Labeling · Supplement 11AP
1987-07-31Labeling · Supplement 9AP
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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