Application 020971
- Type
- NDA
- Sponsor
- DEPROCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEPTOCAINE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | Yes | Yes |
| 002 | SEPTOCAINE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | INJECTABLE;INJECTION | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020971-001 | SEPTOCAINE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | |
| N020971-002 | SEPTOCAINE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2000-04-03 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2000-04-03 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2000-04-03 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2000-04-03 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020971-001 | SEPTOCAINE | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2000-04-03 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020971-002 | SEPTOCAINE | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2006-03-30 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020971-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N020971-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020971-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020971-001 | AP | 1 | ea99ee380514… |
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 AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | 636cbf11-819c-48f8-915d-ac5fb38bd352 | 2026-03-26 | Warnings, Adverse reactions | 020971 NDA020971 |
| Septocaine and Epinephrine | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Septodont Inc. | 0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03 | 2024-10-23 | Warnings, Adverse reactions | 020971 NDA020971 0362-9049 0362-9048 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | fc908011-5e5e-459a-a666-d41426504703 | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 |
| Zorcaine | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | 1767d606-69b8-419e-840f-36550ed91b8f | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 0362-0830 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Patterson Dental | 2b5a7ee3-71ee-4c41-ad9f-852f170470b3 | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 50227-1050 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | NDC, Inc. | 0b0cbbec-8216-434f-892e-226c89d7239c | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 43128-101 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | cc7ff594-2204-44b2-8f81-bcb9c7e9360b | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | f26a084b-ab25-4ca2-8f58-705a4219bf32 | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Patterson Dental | 406de6e6-40f5-44c5-a109-3be0b9d48e58 | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 50227-1040 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | NDC, Inc. | 60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df | 2024-03-06 | Warnings, Adverse reactions | 020971 NDA020971 43128-102 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Benco Dental | d47d7842-930e-41db-9631-d1aba0f05ae0 | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 66975-417 |
| Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein | d9402ac2-fedd-4fb0-90a3-2c466a786526 | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 0404-6625 0404-6620 |
| Articadent | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Dentsply Pharmaceutical | 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00 | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 66312-601 66312-602 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | c4bba4ab-2b20-43e6-92ea-9ec6f1fce754 | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Novocol Pharmaceutical of Canada, Inc. | 854399ec-f7d6-4eab-87bb-94c2b442ec3e | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 |
| ARTICAINE | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE | Benco Dental | 4524cb96-40f7-471f-bfc6-1dcab47628ec | 2024-03-01 | Warnings, Adverse reactions | 020971 NDA020971 66975-418 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0362-0830 | Zorcaine | Articaine Hydrochloride and Epinephrine | Septodont, Inc. | NDA | Current |
| 0362-0830 | Zorcaine | Articaine Hydrochloride and Epinephrine | Septodont, Inc. | NDA | Current |
| 0362-9048 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9048 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9048 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9048 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9049 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9049 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9049 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0362-9049 | Septocaine and Epinephrine | Articaine Hydrochloride and Epinephrine Bitartrate | Septodont Inc. | NDA | Current |
| 0404-6620 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6620 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6620 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6620 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6620 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6625 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6625 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6625 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 0404-6625 | Articaine Hydrochloride and Epinephrine | Articaine Hydrochloride and Epinephrine | Henry Schein | NDA | Current |
| 31382-830 | Zorcaine | Articaine hydrochloride and Epinephrine Bitartrate | Carestream Health, Inc. | NDA | Current |
| 43128-101 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 43128-101 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 43128-101 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 43128-102 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 43128-102 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 43128-102 | ARTICAINE | Articaine Hydrochloride and Epinephrine | NDC, Inc. | NDA | Current |
| 50227-1040 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 50227-1040 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 50227-1040 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 50227-1050 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 50227-1050 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 50227-1050 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Patterson Dental | NDA | Current |
| 66312-601 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | ANDA | Current |
| 66312-601 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | NDA | Current |
| 66312-601 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | NDA | Current |
| 66312-602 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | ANDA | Current |
| 66312-602 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | NDA | Current |
| 66312-602 | Articadent | Articaine hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | NDA | Current |
| 66975-417 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
| 66975-417 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
| 66975-417 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
| 66975-418 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
| 66975-418 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
| 66975-418 | ARTICAINE | Articaine Hydrochloride and Epinephrine | Benco Dental | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56378 | SUPPL | 2018-11-08 |
| 56266 | SUPPL | 2018-11-05 |
| 21311 | SUPPL | 2015-01-28 |
| 21310 | SUPPL | 2015-01-28 |
| 41847 | SUPPL | 2013-06-03 |
| 21309 | SUPPL | 2013-06-03 |
| 3869 | SUPPL | 2010-11-18 |
| 35732 | SUPPL | 2010-03-03 |
| 3868 | SUPPL | 2010-02-26 |
| 26311 | SUPPL | 2006-11-14 |
| 13829 | SUPPL | 2006-11-13 |
| 3867 | SUPPL | 2005-02-08 |
| 3866 | SUPPL | 2004-10-18 |
| 21308 | ORIG | 2002-08-14 |
| 13828 | ORIG | 2000-04-03 |
| 3865 | ORIG | 2000-04-03 |