Application 017549
- Type
- NDA
- Sponsor
- MERIDIAN MEDCL TECHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOPEN | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017549-001 | LIDOPEN | LIDOCAINE HYDROCHLORIDE | 10% | 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 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017549-001 | LIDOPEN | 10% | INJECTABLE / INJECTION | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Bryant Ranch Prepack | ed43f2c3-606c-4998-8fca-ee9b13cd18db | 2023-09-26 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Accucaine | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | 584642a8-9bed-4d86-bfaf-99018c180e34 | 2023-08-09 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bcdbee5-014e-6b4c-e053-2a91aa0aecd2 | 2023-05-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 8968c61e-2686-0fe6-e053-2a95a90a15fa | 2023-05-23 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 858f3faa-e56e-51f9-e053-2a91aa0aa721 | 2023-05-23 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bdd64a8-b90e-57d4-e053-2a91aa0a3911 | 2023-05-22 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6947af02-f4e0-7f9c-e053-2a91aa0a45cd | 2023-05-22 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86083fea-c064-4ef7-e053-2a91aa0ac17c | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 86093c75-6dde-bb16-e053-2991aa0ab6ef | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 79798b21-026d-1b4c-e053-2a91aa0a0129 | 2023-05-16 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 89691444-7bfb-3314-e053-2a95a90a268e | 2023-05-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9c9655fd-89a9-77c8-e053-2a95a90a0c99 | 2023-05-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e412b4c-e24f-69ea-e053-2995a90ac600 | 2023-05-10 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e049bbe-0f4d-988e-e053-2a95a90a3691 | 2023-05-10 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | b63614eb-8776-4cd0-e053-2995a90a8f82 | 2023-05-04 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee | 2023-04-27 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | c8e8b217-a183-0d91-e053-2a95a90a4a44 | 2023-04-25 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Asclemed USA, Inc. | 55a8372e-70d6-4b70-ac95-5226d0f5812a | 2023-03-02 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| PharmapureRx Lidocaine HCl 4.12% | LIDOCAINE HYDROCHLORIDE | PureTek Corporation | b7a77ad1-821b-4388-a97c-aadb1340c536 | 2023-01-11 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | International Medication Systems, Limited | 5d3e9984-cef9-46f2-a6c9-3be8b26f45b3 | 2022-12-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.