Application 022466
- Type
- NDA
- Sponsor
- PIERREL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | Yes | No |
| 002 | ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022466-001 | ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | |
| N022466-002 | ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE | Burkhart Dental Supply Co., Inc | 4f11bb06-c71b-4d96-9baa-2a17ad473a05 | 2024-11-18 | Warnings, Adverse reactions | 022466 NDA022466 |
| Articaine HCl and Epinephrine | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Safco Dental Supply Co. | 0536a4de-578d-497e-a01b-0b1887344cc8 | 2023-01-14 | Warnings, Adverse reactions | 022466 NDA022466 67239-0210 67239-0209 |
| Orabloc | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Pierrel S.p.A. | d18424f0-a691-11dd-ad8b-0800200c9a66 | 2018-11-22 | Warnings, Adverse reactions | 022466 NDA022466 45146-120 45146-110 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45146-110 | Orabloc | articaine hydrochloride and epinephrine bitartrate | Pierrel S.p.A. | NDA | Current |
| 45146-110 | Orabloc | articaine hydrochloride and epinephrine bitartrate | Pierrel S.p.A. | NDA | Current |
| 45146-120 | Orabloc | articaine hydrochloride and epinephrine bitartrate | Pierrel S.p.A. | NDA | Current |
| 45146-120 | Orabloc | articaine hydrochloride and epinephrine bitartrate | Pierrel S.p.A. | NDA | Current |
| 67239-0209 | Articaine HCl and Epinephrine | articaine hydrochloride and epinephrine bitartrate | Safco Dental Supply Co. | NDA | Current |
| 67239-0209 | Articaine HCl and Epinephrine | articaine hydrochloride and epinephrine bitartrate | Safco Dental Supply Co. | NDA | Current |
| 67239-0210 | Articaine HCl and Epinephrine | articaine hydrochloride and epinephrine bitartrate | Safco Dental Supply Co. | NDA | Current |
| 67239-0210 | Articaine HCl and Epinephrine | articaine hydrochloride and epinephrine bitartrate | Safco Dental Supply Co. | NDA | Current |
| 72304-015 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |
| 72304-015 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |
| 72304-015 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |
| 72304-016 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |
| 72304-016 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |
| 72304-016 | Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | Midway Dental Supply, LLC | NDA | Current |