Application 020749
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | SOLUTION;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020749-001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | 1% | SOLUTION / TOPICAL | 1997-10-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | f41ea6bd6efb… |
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 | Karo Healthcare Inc. | 0f59271d-997f-4dcc-aae3-900b53df1c95 | 2025-01-09 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Dr.Reddys Laboratories Limited | e0b309a5-bebe-c6da-2847-bda21aa488b1 | 2024-12-19 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| terbinafine hydrochloride | TERBINAFINE HYDROCHLORIDE | Bionpharma Inc. | 34221c17-0d8c-4b56-8af3-c74efab4599e | 2024-12-18 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| terbinafine hydrochloride | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | 8f6d7b1a-5a01-4cc5-b5b7-c126ae889557 | 2024-10-14 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | Proficient Rx LP | 0a54cc4f-0789-46ce-875f-df759aa95d9c | 2024-09-01 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Bryant Ranch Prepack | 17e976c6-ee44-42c5-987f-5360ee6d7c1e | 2024-08-29 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 5d01fde5-e4cf-6670-e053-2991aa0a5b15 | 2024-07-15 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 87af930f-493c-590e-e053-2a95a90a804a | 2024-06-14 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 715cae3e-4e86-48b3-e053-2a95a90afdc2 | 2024-06-10 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | Bryant Ranch Prepack | 294bc1af-50e3-4bff-8d48-321e673033ce | 2024-05-30 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | 79a39fb1-12b7-4b1e-9f28-102af34d0459 | 2024-05-23 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | Aurobindo Pharma Limited | 6600e2b3-65df-4fc3-8081-d574537d27e3 | 2024-04-18 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | NorthStar Rx LLC | 8f87e3e1-4c9c-497a-af20-8ab52cfeef60 | 2024-04-18 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | Proficient Rx LP | 50657431-1cd9-42dd-9cfc-57db8713d267 | 2024-04-01 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Bryant Ranch Prepack | e2ecf7a5-1c84-4977-8a87-d1bfb9658668 | 2024-02-07 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | c3832113-f517-4b4e-bf9c-31fce1a638e1 | 2023-12-22 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | ef8370dc-8ca4-411d-87e1-dc6af3191330 | 2023-12-09 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | 6605103b-fd71-4438-8496-f48973b98901 | 2023-10-31 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Proficient Rx LP | 4e515f99-7fc7-4692-9105-8e87c27d4e79 | 2022-08-01 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Proficient Rx LP | 76f7525d-2005-4da8-a795-50ede6236c68 | 2022-07-01 | Warnings | TERBINAFINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.