Application 208660
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE | LIDOCAINE | OINTMENT;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208660-001 | LIDOCAINE | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208660-001 | AT |
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 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 5aa47cf7b7d7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208660-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2021-01-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208660-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208660-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208660-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208660-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208660-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208660-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208660-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208660-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208660-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208660-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208660-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208660-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208660-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208660-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208660-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208660-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208660-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208660-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208660-001 | AT | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A208660-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208660-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208660-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208660-001 | AT | 1 | 5aa47cf7b7d7… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208660-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208660-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208660-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208660-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208660-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208660-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208660-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208660-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208660-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208660-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208660-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A208660-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208660-001 | AT | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208660-001 | AT | 1 | 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 |
|---|---|---|---|---|---|---|
| Bactine Max Antibiotic and Lidocaine Max Pain Relief | LIDOCAINE | WellSpring Pharmaceutical Corporation | 71300df9-6113-4f25-93ca-28ad7e7f79de | 2023-06-08 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Proficient Rx LP | 2b9150ea-a876-4511-8d5b-aa72507ef863 | 2023-06-01 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86083fea-c064-4ef7-e053-2a91aa0ac17c | 2023-05-16 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86093c75-6dde-bb16-e053-2991aa0ab6ef | 2023-05-16 | Warnings, Adverse reactions | Lidocaine |
| Bactine Max Lidocaine Roll-on 2.5oz | LIDOCAINE | WellSpring Pharmaceutical Corporation | 09b32a98-9131-451e-87a6-81a1e4ed7ec5 | 2023-04-25 | Warnings | LIDOCAINE |
| lidocaine | LIDOCAINE | Asclemed USA, Inc. | 58c9afe4-dc36-4f71-8e76-8dff63dc35fb | 2023-03-27 | Warnings, Adverse reactions | lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | a134c265-4fb6-4c78-b9cc-fae8f1fff1cf | 2023-03-15 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | 68bc320f-2871-45b9-815e-bb26081e8249 | 2023-03-02 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | da9707e2-f830-45e2-a300-1f99cf3dd362 | 2023-02-20 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | QUAGEN PHARMACEUTICALS LLC | f8789807-cc0c-485c-aa98-1bdc39337deb | 2023-02-15 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| lidocaine | LIDOCAINE | Proficient Rx LP | 8a85ea77-91ad-4222-9bfe-2ffaf73182e8 | 2022-11-01 | Warnings, Adverse reactions | lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Asclemed USA, Inc. | 80dadfb5-cbe6-475f-9980-a1b255982753 | 2022-10-12 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| lidocaine | LIDOCAINE | Proficient Rx LP | f9b290d2-0e24-4ca8-bca2-3016f5c404df | 2022-05-01 | Warnings, Adverse reactions | lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Actavis Pharma, Inc. | 4d04052c-3e0a-469a-9265-99604f13e507 | 2022-04-30 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Proficient Rx LP | 2c396307-cf12-41d0-89e6-0f4ec74df55e | 2022-04-01 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| lidocaine | LIDOCAINE | Asclemed USA, Inc. | 6abf3773-0e60-48b1-9d5c-adc590363d13 | 2021-08-09 | Warnings, Adverse reactions | lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Proficient Rx LP | f1007717-528a-42e2-94aa-db0edf3bb603 | 2021-01-01 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidoxryl | LIDOCAINE | PureTek Corporation | 1c33790b-8d57-46e8-bd6e-5a0f87a3c29f | 2020-11-10 | Warnings, Adverse reactions | LIDOCAINE |
| LidoPure Patch | LIDOCAINE | PureTek Corporation | c851c6e9-1966-4639-9406-fe6adc91c9d0 | 2020-11-10 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE | Asclemed USA, Inc. | c18f0c2b-cd05-4458-888f-47b4a1106937 | 2020-11-03 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.