Data updated: Mar 10, 2026
LAMISIL
TERBINAFINE HYDROCHLORIDE
Approved 1992-12-30
9
Indications
--
Phase 3 Trials
33
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1992-12-30
- Routes
- TOPICAL, ORAL
- Dosage Forms
- CREAM, TABLET, GEL, SOLUTION, GRANULE
LAMISIL Approval History
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What LAMISIL Treats
9 FDA approvalsOriginally approved for its first indication in 1992 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Dec 1992)
- • Approved indication (May 1996)Letter
- • Approved indication (Jan 1997)
- • Approved indication (Oct 1997)
- • Approved indication (Apr 1998)Label Letter
- • Approved indication (Jan 1999)
- • Approved indication (Mar 1999)Letter
- • Approved indication (Jul 1999)Label Letter
- • Approved indication (Sep 2007)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LAMISIL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.