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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020749-001 | LAMISIL | 1% | SOLUTION / TOPICAL | 1997-10-17 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| terbinafine hydrochloride | TERBINAFINE HYDROCHLORIDE | REMEDYREPACK INC. | 2886b2ff-815f-4621-bc28-1fea082c1920 | 2026-07-09 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Athlete Foot Cream | TERBINAFINE HYDROCHLORIDE | Beautivity LLC | 3b2c1d7f-32c3-aa3b-e063-6394a90a6267 | 2026-06-29 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Scholl's Wellness Company LLC | 31f59302-eaee-211b-e063-6294a90a08b0 | 2026-04-03 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | American Health Packaging | 4ee1b667-0cf6-46e4-a740-4fc27904d577 | 2026-03-06 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 92b31fc4-0f02-4857-b11f-49b9f942ee84 | 2026-02-20 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | REMEDYREPACK INC. | 44c6f6e7-e0c0-450e-83ce-1ed4f3efddec | 2026-02-13 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Northwind Health Company, LLC | ab6f50a5-87ce-0819-e053-2a95a90a22b7 | 2026-01-01 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | 5de4c245-7086-453b-b90a-7a1242ec2c0b | 2025-12-18 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 21f1bf77-4338-4b75-b513-80a0d98a722a | 2025-12-12 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Lamisil AT | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | d3e75665-e2d4-47d9-baaa-93817b5fbf00 | 2025-12-12 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Walgreens Athletes Foot | TERBINAFINE HYDROCHLORIDE | Walgreen Company | d706c56f-0123-4a5a-8c85-240cbe6ef7a5 | 2025-11-26 | Warnings | TERBINAFINE HYDROCHLORIDE |
| CVS | TERBINAFINE HYDROCHLORIDE | CVS Pharmacy | 17684ba2-3c2c-4259-84fa-3833f19e5a4d | 2025-11-25 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | b43e4644-024c-4aa6-b403-19152c785802 | 2025-11-25 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Lamisil AT Cream | TERBINAFINE HYDROCHLORIDE | Voyant Beauty Inc. | 9dea4789-bf1c-1577-e053-2a95a90a5381 | 2025-11-18 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Good Neighbor Pharmacy | TERBINAFINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0a9e890c-1eed-4fde-a484-852a4dd135c2 | 2025-10-17 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2df111dc-ecac-4161-9e22-38436eb37c1f | 2025-10-17 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 747fdc13-7c3a-4672-b50c-31c51037bda2 | 2025-10-14 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |
| Lamisil AT Cream | TERBINAFINE HYDROCHLORIDE | Karo Healthcare Inc. | 1aa5e03a-432b-4154-ab6e-6dbce7a67109 | 2025-10-02 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 6016e546-6c02-4af0-888c-c0899865c5f0 | 2025-09-30 | Warnings | TERBINAFINE HYDROCHLORIDE |
| Terbinafine | TERBINAFINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 085e0809-6b7f-447e-976e-8276c29daad6 | 2025-09-30 | Warnings, Adverse reactions | TERBINAFINE HYDROCHLORIDE |