Application 021124
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL AT | TERBINAFINE HYDROCHLORIDE | SOLUTION;TOPICAL | 1% | Yes | Yes |
| 002 | LAMISIL AT | TERBINAFINE HYDROCHLORIDE | SPRAY;TOPICAL | 1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021124-001 | LAMISIL AT | TERBINAFINE HYDROCHLORIDE | 1% | SOLUTION / TOPICAL | RLD, RS | 2000-03-17 | |
| N021124-002 | LAMISIL AT | TERBINAFINE HYDROCHLORIDE | 1% | SPRAY / TOPICAL | RLD, RS | 2000-03-17 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | N021124-001 | LAMISIL AT | 1% | SOLUTION / TOPICAL | RLD, RS | 2000-03-17 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021124-002 | LAMISIL AT | 1% | SPRAY / TOPICAL | RLD, RS | 2000-03-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021124-001 | LAMISIL AT | 1% | SOLUTION / TOPICAL | RLD, RS | 2000-03-17 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021124-002 | LAMISIL AT | 1% | SPRAY / TOPICAL | RLD, RS | 2000-03-17 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021124-001 | LAMISIL AT | 1% | SOLUTION / TOPICAL | RLD, RS | 2000-03-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021124-002 | LAMISIL AT | 1% | SPRAY / TOPICAL | RLD, RS | 2000-03-17 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 21f1bf77-4338-4b75-b513-80a0d98a722a | 2025-12-12 | Warnings | 021124 NDA021124 |
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | d3e75665-e2d4-47d9-baaa-93817b5fbf00 | 2025-12-12 | Warnings | 021124 NDA021124 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0067-6292 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6292 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6293 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer | NDA | Current |
| 0067-6296 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6296 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6296 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6297 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6297 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-6297 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |