ORABLOC 1:100,000 DIN 02361914
Health Canada record
| Active ingredient(s) | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE BITARTRATE 0.018 MG |
|---|---|
| Dosage form | Solution |
| Route | Block/Infiltration |
| Schedule | ETHICAL |
| Class | Human |
| ATC | N01BB58 ARTICAINE, COMBINATIONS |
| Original market date | 14-Jun-2012 |
| Current status date | 18-May-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pierrel S.P.A. — licence , not currently licensed, last inspection rating C (2023-03-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ARTICAINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02248489 | 4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML) | DENTSPLY CANADA LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005 MG | Marketed |
| 02248488 | 4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML) | DENTSPLY CANADA LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Marketed |
| 02339544 | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION | PIERREL S.P.A. | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE BITARTRATE 0.018 MG | Marketed |
| 02339536 | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION | PIERREL S.P.A. | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE BITARTRATE 0.009 MG | Marketed |
| 02561980 | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - N | SEPTODONT | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005 MG | Marketed |
| 02561999 | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - SP | SEPTODONT | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Marketed |
| 02361906 | ORABLOC 1:200,000 | PIERREL S.P.A. | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE BITARTRATE 0.009 MG | Marketed |
| 02381311 | POSICAINE N | NOVOCOL PHARMACEUTICAL OF CANADA INC | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005 MG | Marketed |
| 02381338 | POSICAINE SP | NOVOCOL PHARMACEUTICAL OF CANADA INC | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Marketed |
| 02123371 | SEPTANEST N | SEPTODONT | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005 MG | Marketed |
| 02123398 | SEPTANEST SP | SEPTODONT | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Marketed |
| 01988557 | ULTRACAINE D-S FORTE INJECTION | HANSAMED LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE 0.01 MG | Marketed |
| 01988530 | ULTRACAINE D-S INJECTION | HANSAMED LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE 5 MCG | Marketed |
| 02230169 | 4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML) | DENTSPLY CANADA LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE 0.005 MG | Cancelled Post Market |
| 02230168 | 4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML) | DENTSPLY CANADA LIMITED | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE 0.01 MG | Cancelled Post Market |
| 00538566 | ULTRACAINE DS FORTE INJ | HOECHST CANADA INC. | Liquid | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE .01 MG | Cancelled Post Market |
| 00538558 | ULTRACAINE DS INJ | HOECHST CANADA INC. | Liquid | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE 5 MCG | Cancelled Post Market |
| 02260646 | ZORCAINE | CARESTREAM HEALTH CANADA COMPANY | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Cancelled Post Market |
| 02474239 | ZORCAINE | SEPTODONT | Solution | ARTICAINE HYDROCHLORIDE 40 MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30105 | 2023-02-09 | Abbreviated New Drug Submission (ANDS) | Administrative: Merger/Buy-out |
| 20294 | 2018-01-11 | Abbreviated New Drug Submission (ANDS) | TRANSFER OF DRUG IDENTIFICATION NUMBER |
| 12066 | 2011-02-11 | Abbreviated New Drug Submission (ANDS) | Additional product name |
International API supply for ARTICAINE HYDROCHLORIDE
9 valid EDQM Certificates of Suitability from 9 holders. 4 active FDA Drug Master Files.
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