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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | caaa826d4ba7… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Curist Antifungal Relief | TERBINAFINE HYDROCHLORIDE | Little Pharma, Inc. | 28f13725-48d1-8774-e063-6394a90a6704 | 2025-06-15 | Warnings | 077511 ANDA077511 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | A-S Medication Solutions | ef8370dc-8ca4-411d-87e1-dc6af3191330 | 2023-12-09 | Warnings | 077511 ANDA077511 50090-1278 |
| Terbinafine Hydrochloride | TERBINAFINE HYDROCHLORIDE | Proficient Rx LP | 76f7525d-2005-4da8-a795-50ede6236c68 | 2022-07-01 | Warnings | 077511 ANDA077511 63187-111 |
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 |
|---|---|---|---|---|---|
| 0067-8100 | 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 |