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 |
|---|---|---|---|---|---|---|
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Advanced Rx of Tennessee, LLC | 3a9a6630-e470-b794-e063-6394a90aaab5 | 2025-07-23 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Arthcal 4% Lidocaine Patches | LIDOCAINE | Beijing JUNGE Technology Co., Ltd. | 2e531194-67ad-c645-e063-6394a90a916c | 2025-07-22 | Warnings | LIDOCAINE |
| LIDOCAINE | LIDOCAINE | PHOENIX RX LLC | 3a63652c-92a1-612b-e063-6294a90a034a | 2025-07-21 | Warnings, Adverse reactions | LIDOCAINE LIDOCAINE |
| OTC Rescue Lidocaine Pain Relief Patch | LIDOCAINE | Veridian Healthcare | 0e742fc6-5f76-d202-e063-6394a90acf31 | 2025-07-16 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Golden State Medical Supply, Inc. | b948d6fe-3893-39a1-e053-2995a90ae64c | 2025-07-11 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| INVIGOR OH | LIDOCAINE | Natureplex LLC | 7c7b536d-e41a-4017-9df9-982e2e9cfe4e | 2025-07-10 | Warnings | LIDOCAINE |
| LIDOCAINE | LIDOCAINE, MENTHOL | Vive Health LLC | 236ccc6d-21b7-6153-e063-6394a90a4634 | 2025-07-02 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Sun Pharmaceutical Industries, Inc. | ae758020-a508-4a2e-8164-e6c324e826a3 | 2025-07-02 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Syntherma Plus | LIDOCAINE | V2 Pharma, LLC | 1a312322-9c4a-4f14-be7f-05ccad1601bf | 2025-07-01 | Warnings, Adverse reactions | LIDOCAINE |
| 4 Lidocaine Topical Anesthetic | LIDOCAINE | RUGBY LABORATORIES | 63327e57-f4c8-4ae6-9d28-cef8697bbdcc | 2025-06-27 | Warnings | LIDOCAINE |
| Orythia Pain Relieving Lidocaine | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | d658d495-dd2c-40b7-9446-6f10040ed55e | 2025-06-27 | Warnings | LIDOCAINE |
| Lidocaine Patch | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 3875bde5-2e1a-5fdf-e063-6294a90a3c0d | 2025-06-26 | Warnings | LIDOCAINE |
| Medline | LIDOCAINE | Medline Industries, LP | 0d6d0d4e-60d5-74b2-e063-6294a90a2da6 | 2025-06-26 | Warnings | LIDOCAINE |
| Hilook Blue Gel Anesthetic | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 1b9db681-a297-5aa9-e063-6394a90a80ea | 2025-06-25 | Warnings | LIDOCAINE |
| Hilook Numbing Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 1b9f1a4c-ca0b-d820-e063-6394a90a3239 | 2025-06-25 | Warnings | LIDOCAINE |
| Lidocaine Knee Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 384c1ff8-80bd-86cb-e063-6394a90a2d65 | 2025-06-24 | Warnings | LIDOCAINE |
| Elemar Patch | LIDOCAINE | V2 Pharma, LLC | 3de6bb95-3673-45c4-bf11-90ec858c37d9 | 2025-06-20 | Warnings, Adverse reactions | LIDOCAINE |
| MyDerm | LIDOCAINE | Inspec Solutions LLC. | 82d075d1-c92e-2097-e053-2991aa0ab131 | 2025-06-18 | Warnings | LIDOCAINE |
| Walgreens Extra Small Lidocaine | LIDOCAINE | Walgreen Co. | dc838e47-d234-4ba5-9449-f645e99be923 | 2025-06-18 | Warnings | LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.