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FDA NDA · NDA020192

LAMISIL

Sponsor: NOVARTIS

APPLICATION
NDA020192
TYPE
NDA
ORIGINAL APPROVAL
1992-12-30
LATEST ACTION
1998-09-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

LAMISILDiscontinued
TERBINAFINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

1998-09-03Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
1997-06-30Manufacturing (CMC) · Supplement 13 · standard — Review ↗AP
1997-04-03Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1997-01-21Efficacy · Supplement 3 · standard — Review ↗AP
1997-01-21Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
1996-12-06Manufacturing (CMC) · Supplement 9 · standardAP
1996-10-04Manufacturing (CMC) · Supplement 10 · standardAP
1996-08-08Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1995-10-17Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1995-04-25Manufacturing (CMC) · Supplement 4 · standardAP
1993-08-04Manufacturing (CMC) · Supplement 2 · standardAP
1992-12-30Type 1 - New Molecular Entity · Original · standardAP
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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