Application 021958
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL AT | TERBINAFINE | GEL;TOPICAL | 1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021958-001 | LAMISIL AT | TERBINAFINE | 1% | GEL / TOPICAL | RLD, RS | 2006-07-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021958-001 | LAMISIL AT | 1% | GEL / TOPICAL | RLD, RS | 2006-07-24 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021958-001 | LAMISIL AT | 1% | GEL / TOPICAL | RLD, RS | 2006-07-24 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021958-001 | LAMISIL AT | 1% | GEL / TOPICAL | RLD, RS | 2006-07-24 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021958-001 | LAMISIL AT | 1% | GEL / TOPICAL | RLD, RS | 2006-07-24 | 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 |
|---|---|---|---|---|---|---|
| Toenail Fungus Treatment | TERBINAFINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4dc1d7f7-e4ae-c54b-e063-6394a90aa420 | 2026-03-24 | Warnings | TERBINAFINE |
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 21f1bf77-4338-4b75-b513-80a0d98a722a | 2025-12-12 | Warnings | Lamisil AT |
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | d3e75665-e2d4-47d9-baaa-93817b5fbf00 | 2025-12-12 | Warnings | Lamisil AT |
| Terbinafine | TERBINAFINE | Cipla USA Inc. | 18b16aad-1877-4b07-b532-f0ef4843af91 | 2025-09-19 | Warnings, Adverse reactions | TERBINAFINE |
| TERBINAFINE | TERBINAFINE | direct rx | c7cf55e2-f637-e2d9-e053-2995a90a6270 | 2025-01-20 | Warnings, Adverse reactions | TERBINAFINE |
| TERBINAFINE | TERBINAFINE | Chartwell RX, LLC | 8ea693ec-e2f2-4661-b144-17651018e9fb | 2024-11-07 | Warnings, Adverse reactions | TERBINAFINE |
| Terbinafine | TERBINAFINE | Exelan Pharmaceuticals Inc. | 6dc279cc-9861-4fa8-8083-ca3b3c57b513 | 2020-10-29 | Warnings, Adverse reactions | TERBINAFINE |
| Terbinafine | TERBINAFINE | Proficient Rx LP | 3925dc10-ad66-46a8-bfa5-1a4314be3521 | 2020-01-01 | Warnings, Adverse reactions | TERBINAFINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.