Application 020980
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | CREAM;TOPICAL | 1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020980-001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 |
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 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 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 Cream | TERBINAFINE HYDROCHLORIDE | Voyant Beauty Inc. | 9dea4789-bf1c-1577-e053-2a95a90a5381 | 2025-11-18 | Warnings | 020980 NDA020980 61047-120 |
| Lamisil AT Cream | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 1aa5e03a-432b-4154-ab6e-6dbce7a67109 | 2025-10-02 | Warnings | 020980 NDA020980 |
| LAMISIL AT TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | Voyant Beauty, Inc. | 1fd313ad-a3d9-6c86-e063-6394a90a7ae4 | 2025-09-17 | Warnings | 020980 NDA020980 |
| Lamisil AT Cream | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 7f8434c2-60c9-4aeb-b0b8-f69107e74609 | 2025-01-09 | Warnings | 020980 NDA020980 |
| Lamisil AT Cream | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 0f59271d-997f-4dcc-aae3-900b53df1c95 | 2025-01-09 | Warnings | 020980 NDA020980 |
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 |
|---|---|---|---|---|---|
| 0067-3998 | Lamisil | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0067-3999 | Lamisil | TERBINAFINE HYDROCHLORIDE | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 11673-401 | athletes foot | terbinafin hydrochloride | Target Corporation | NDA | Current |
| 61047-120 | Lamisil AT Cream | Terbinafine Hydrochloride | KIK HOLDCO COMPANY INC. | NDA | Current |
| 61047-120 | Lamisil AT Cream | Terbinafine Hydrochloride | Voyant Beauty Inc. | NDA | Current |