Application 088653
- Type
- ANDA
- Sponsor
- DENTSPLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POLOCAINE | MEPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 3% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088653-001 | POLOCAINE | MEPIVACAINE HYDROCHLORIDE | 3% | INJECTABLE / INJECTION | 1984-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A088653-001 | POLOCAINE | 3% | INJECTABLE / INJECTION | 1984-08-21 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Scandonest 3% Plain | MEPIVACAINE HYDROCHLORIDE | Septodont, Inc. | af6ff5f6-7221-421b-9b7c-8fcee4a47772 | 2025-05-29 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| MEPIVACAINE HYDROCHLORIDE | MEPIVACAINE HYDROCHLORIDE | Safco Dental Supply Co. | c4d45717-86c9-45bf-ba8e-2c255814ab50 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Novocol Pharmaceutical of Canada, Inc. | f58cb2c7-22a6-4341-8f9a-85c5628af797 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Darby Dental Supply, LLC | 5e81dae6-e55b-4d5e-9318-1d9395db052e | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine Hydrochloride | MEPIVACAINE HYDROCHLORIDE | Henry Schein Inc. | a3c2cddc-827b-4644-9060-e2fd2188b459 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Carbocaine | MEPIVACAINE HYDROCHLORIDE | Septodont, Inc. | 1f2f9e40-e437-4124-97b7-df67dbafd154 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Polocaine | MEPIVACAINE HYDROCHLORIDE | Novocol Pharmaceutical of Canada Inc. | eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf | 2024-02-21 | Warnings, Adverse reactions | Polocaine MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Benco Dental | c9a5a849-d010-4637-a66a-c26176401fbd | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | NDC, Inc. | 042010fb-7161-4336-b91f-5a25839ee644 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Mepivacaine | MEPIVACAINE HYDROCHLORIDE | Patterson Dental Supply, Inc. | e8a3df4b-e918-4813-af3e-3c95f2c54250 | 2024-02-21 | Warnings, Adverse reactions | MEPIVACAINE HYDROCHLORIDE |
| Polocaine | MEPIVACAINE HYDROCHLORIDE | Dentsply Pharmaceutical | 25074a6a-7f67-4ad8-86e0-2afe23ec5d04 | 2024-02-21 | Warnings, Adverse reactions | Polocaine MEPIVACAINE HYDROCHLORIDE |
| Polocaine-MPF | MEPIVACAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | a27d0815-ae6b-4a21-a8f5-564c01e83814 | 2022-10-01 | Warnings, Adverse reactions | Polocaine MEPIVACAINE HYDROCHLORIDE |