← FDA DRUG APPROVALS

FDA NDA · NDA021124

LAMISIL AT

terbinafine hydrochloride

Sponsor: KARO HLTHCARE

APPLICATION
NDA021124
TYPE
NDA
ORIGINAL APPROVAL
2000-03-17
LATEST ACTION
2019-07-18
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION, SPRAY
MARKETING STATUS
Over-the-counter

Products

LAMISIL AT · ReferenceOver-the-counter
TERBINAFINE HYDROCHLORIDE 1% · SOLUTION · TOPICAL
LAMISIL AT · ReferenceOver-the-counter
TERBINAFINE HYDROCHLORIDE 1% · SPRAY · TOPICAL

Approval history

2019-07-18Manufacturing (CMC) · Supplement 15AP
2018-10-18Labeling · Supplement 16 · standard — Letter ↗AP
2013-11-13Labeling · Supplement 13 · standard — Label ↗AP
2012-03-20Labeling · Supplement 11 · standard — Letter ↗AP
2010-02-12Labeling · Supplement 9 · standard — Letter ↗AP
2009-06-15Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2008-07-25Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2002-07-25Manufacturing (CMC) · Supplement 4 · standardAP
2002-04-08Manufacturing (CMC) · Supplement 3 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 2 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 1 · standardAP
2000-03-17Type 8 - Partial Rx to OTC Switch · Original · standard — Review ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →