Application 077511
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | CREAM;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077511-001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 |
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 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0067-8100 | Lamisil AT | Terbinafine Hydrochloride | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ANDA | Current |
| 0067-8100 | Lamisil AT | Terbinafine Hydrochloride | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ANDA | Current |
| 0067-8114 | Lamisil AT | Terbinafine Hydrochloride | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ANDA | Current |
| 0067-8114 | Lamisil AT | Terbinafine Hydrochloride | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ANDA | Current |
| 0179-8715 | KAISER PERMANENTE | Terbinafine Hydrochloride | Kaiser Foundation Hospitals | ANDA | Current |
| 0363-2080 | Walgreens | Terbinafine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-2080 | Walgreens | Terbinafine Hydrochloride | Walgreen Company | ANDA | Current |
| 0363-2083 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Walgreen Company | ANDA | Current |
| 0536-1117 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1117 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Rugby Laboratories, Inc. | ANDA | Current |
| 11673-080 | Athletes Foot | Terbinafine Hydrochloride | Target Corporation | ANDA | Current |
| 11673-080 | Athletes Foot | Terbinafine Hydrochloride | Target Corporation | ANDA | Current |
| 11822-0080 | Athletes Foot | Terbinafine Hydrochloride | Rite Aid Corporation | ANDA | Current |
| 21130-080 | Athletes Foot | Terbinafine Hydrochloride | Safeway Inc. | ANDA | Current |
| 24385-524 | Good Neighbor Pharmacy | Terbinafine Hydrochloride | AmerisourceBergen | ANDA | Current |
| 24385-524 | Good Neighbor Pharmacy | Terbinafine Hydrochloride | AmerisourceBergen | ANDA | Current |
| 30142-080 | Kroger | Terbinafine Hydrochloride | Kroger Company | ANDA | Current |
| 30142-080 | Kroger | Terbinafine Hydrochloride | Kroger Company | ANDA | Current |
| 36800-080 | Athletes Foot | Terbinafine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 37012-080 | Shopko | Terbinafine Hydrochloride | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-941 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Cardinal Health | ANDA | Current |
| 37205-941 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Cardinal Health | ANDA | Current |
| 37808-080 | Athletes Foot | Terbinafine Hydrochloride | H E B | ANDA | Current |
| 41163-080 | athletes foot | Terbinafine Hydrochloride | Supervalu Inc | ANDA | Current |
| 41190-083 | ShopRite | Terbinafine Hydrochloride | WAKEFERN FOOD CORPORATION | ANDA | Current |
| 41250-080 | Antifungal | Terbinafine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-080 | Antifungal | Terbinafine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41250-080 | Antifungal | Terbinafine Hydrochloride | Meijer Distribution Inc | ANDA | Current |
| 41520-080 | Antifungal Foot | Terbinafine Hydrochloride | American Sales Company | ANDA | Current |
| 41520-080 | Antifungal Foot | Terbinafine Hydrochloride | American Sales Company | ANDA | Current |
| 49035-080 | equate | Terbinafine Hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49348-790 | Athletes Foot | Terbinafine Hydrochloride | McKesson | ANDA | Current |
| 49348-790 | Athletes Foot | Terbinafine Hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 50066-080 | Silka | Terbinafine Hydrochloride | Genomma Lab USA, Inc. | ANDA | Current |
| 50066-080 | Silka | Terbinafine Hydrochloride | Genomma Lab USA, Inc. | ANDA | Current |
| 50066-208 | Silka | Terbinafine Hydrochloride | Genomma Lab USA, Inc. | ANDA | Current |
| 50090-1278 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1278 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1278 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1278 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1278 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5810 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5810 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50804-080 | GoodSense | Terbinafine Hydrochloride | Geiss, Destin & Dunn, Inc. | ANDA | Current |
| 51143-080 | Live Better | Terbinafine Hydrochloride | The Great Atlantic & Pacific Tea Company | ANDA | Current |
| 51672-2080 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-2080 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-2083 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-2140 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51769-121 | Silka | Terbinafine Hydrochloride | All Natural Dynamics | ANDA | Current |
| 56062-080 | Athletes Foot | Terbinafine Hydrochloride | Publix Super Markets Inc. | ANDA | Current |
| 59779-080 | CVS Pharmacy | Terbinafine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-080 | CVS Pharmacy | Terbinafine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-080 | CVS Pharmacy | Terbinafine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-523 | CVS | Terbinafine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 59779-523 | CVS | Terbinafine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 61715-158 | Preferred Plus | Terbinafine Hydrochloride | Preferred Plus (Kinray) | ANDA | Current |
| 63187-111 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-111 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-111 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-111 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63868-364 | Athletes Foot | Terbinafine Hydrochloride | Chain Drug Marketing Association, Inc. | ANDA | Current |
| 68016-080 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Pharmacy Value Alliance LLC | ANDA | Current |
| 68788-9814 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9814 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9814 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9814 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9814 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Preferred Pharmaceuticals | ANDA | Current |
| 70000-0338 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Cardinal Health, 110 dba LEADER | ANDA | Current |
| 70000-0338 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | Cardinal Health | ANDA | Current |
| 70518-0553 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0553 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0553 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0670 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0670 | Terbinafine Hydrochloride | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1736 | Lamisil AT | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1736 | Lamisil AT | Terbinafine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 73467-121 | Silka | Terbinafine Hydrochloride | PCGI Wholesale | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43123 | ORIG | 2012-03-28 |