FDA NDA · NDA021958

LAMISIL AT

Sponsor: KARO HLTHCARE

APPLICATION

NDA021958

TYPE

NDA

ORIGINAL APPROVAL

2006-07-24

LATEST ACTION

2013-01-24

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Over-the-counter

Products

LAMISIL AT · ReferenceOver-the-counter

TERBINAFINE 1% · GEL · TOPICAL

2013-01-24Manufacturing (CMC) · Supplement 4 · standardAP

2012-03-20Labeling · Supplement 3 · standard — Letter ↗AP

2010-01-06Labeling · Supplement 2 · standard — Letter ↗AP

2006-07-24Type 8 - Partial Rx to OTC Switch · Original · standard — Letter ↗AP

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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