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FDA NDA · NDA020539

LAMISIL

Sponsor: NOVARTIS

APPLICATION
NDA020539
TYPE
NDA
ORIGINAL APPROVAL
1996-05-10
LATEST ACTION
2019-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LAMISIL · ReferenceDiscontinued
TERBINAFINE HYDROCHLORIDE EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-03-29Labeling · Supplement 33 · standard — Label ↗AP
2017-01-19Labeling · Supplement 29 · standard — Label ↗AP
2016-11-15Manufacturing (CMC) · Supplement 28 · standardAP
2016-11-03Manufacturing (CMC) · Supplement 27 · standardAP
2016-08-23Labeling · Supplement 26 · standard — Letter ↗AP
2016-02-12Manufacturing (CMC) · Supplement 25 · standardAP
2013-10-23Labeling · Supplement 24 · standard — Label ↗AP
2013-06-17Labeling · Supplement 23 · standard — Letter ↗AP
2012-04-23Labeling · Supplement 21 · standard — Letter ↗AP
2011-11-04Labeling · Supplement 20 · standard — Letter ↗AP
2011-03-30Labeling · Supplement 18 · unknown — Letter ↗AP
2010-12-02Labeling · Supplement 17 · unknown — Letter ↗AP
2005-11-10Labeling · Supplement 13 · standardAP
2004-01-21Labeling · Supplement 12 · standard — Label ↗AP
2001-12-27Manufacturing (CMC) · Supplement 11 · standardAP
2001-04-30Manufacturing (CMC) · Supplement 9 · standardAP
2001-04-13Labeling · Supplement 10 · standard — Letter ↗AP
2000-02-01Manufacturing (CMC) · Supplement 8 · standardAP
1999-04-21Manufacturing (CMC) · Supplement 5 · standardAP
1999-01-05Efficacy · Supplement 3 · unknownAP
1996-12-06Manufacturing (CMC) · Supplement 1 · standardAP
1996-10-04Manufacturing (CMC) · Supplement 2 · standardAP
1996-05-10Type 3 - New Dosage Form · Original · standard — Letter ↗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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