Application 080414
- Type
- ANDA
- Sponsor
- MILES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080414-001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080414-002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 |
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 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080414-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080414-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| SunBurnt PLUS Pain Relief | LIDOCAINE HYDROCHLORIDE | Welmedix LLC dba Welmedix Consumer Healthcare | 6363c695-f801-407d-a4e1-b0d9cfa0a273 | 2018-03-13 | Warnings | LIDOCAINE HYDROCHLORIDE |
| FSK-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 4c62196a-9f94-4823-b95f-447f012f10bf | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| EBSS-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 7e21b96a-3d89-4d1c-9ec6-0611f6c9c625 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| IWK-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | f291841e-ccbd-4f5a-b1de-4cf596a167e3 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| EBSL-5 | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 0d2631c1-93fc-478c-afed-0f175a7e8555 | 2017-12-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Unburn | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 0c504ba8-8a40-43dd-8c68-62ed106b32a2 | 2017-12-01 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Unburn | LIDOCAINE HYDROCHLORIDE | Water-Jel Technologies | 40164231-1556-4714-9e27-9d41e3c71447 | 2017-11-30 | Warnings | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.