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FDA NDA · NDA022071

LAMISIL

Sponsor: NOVARTIS

APPLICATION
NDA022071
TYPE
NDA
ORIGINAL APPROVAL
2007-09-28
LATEST ACTION
2019-03-29
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

LAMISIL · ReferenceDiscontinued
TERBINAFINE HYDROCHLORIDE EQ 187.5MG BASE/PACKET · GRANULE · ORAL
LAMISIL · ReferenceDiscontinued
TERBINAFINE HYDROCHLORIDE EQ 125MG BASE/PACKET · GRANULE · ORAL

Approval history

2019-03-29Labeling · Supplement 15 · standard — Label ↗AP
2017-01-19Labeling · Supplement 13 · standard — Label ↗AP
2016-08-23Labeling · Supplement 11 · standard — Letter ↗AP
2013-10-23Labeling · Supplement 10 · standard — Letter ↗AP
2013-06-17Labeling · Supplement 9 · standard — Letter ↗AP
2012-04-23Labeling · Supplement 7 · standard — Letter ↗AP
2011-11-04Labeling · Supplement 6 · standard — Letter ↗AP
2011-03-30Labeling · Supplement 4 · unknown — Letter ↗AP
2010-12-02Labeling · Supplement 3 · unknown — Label ↗AP
2007-09-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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