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FDA NDA · NDA020980

LAMISIL AT CREAM

terbinafine hydrochloride

Sponsor: KARO HLTHCARE

APPLICATION
NDA020980
TYPE
NDA
ORIGINAL APPROVAL
1999-03-09
LATEST ACTION
2019-07-17
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

LAMISIL · ReferenceOver-the-counter
TERBINAFINE HYDROCHLORIDE 1% · CREAM · TOPICAL

Approval history

2019-07-17Labeling · Supplement 12 · standard — Label ↗AP
2014-11-24Manufacturing (CMC) · Supplement 11 · standardAP
2013-09-10Manufacturing (CMC) · Supplement 10 · standardAP
2012-03-20Labeling · Supplement 9 · standard — Letter ↗AP
2009-11-19Labeling · Supplement 7 · standardAP
2007-07-25Labeling · Supplement 5 · standard — Label ↗AP
2001-05-09Manufacturing (CMC) · Supplement 3 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 2 · standardAP
1999-07-22Manufacturing (CMC) · Supplement 1 · standardAP
1999-03-09Type 8 - Partial Rx to OTC Switch · Original · standard — Review ↗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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