DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP DIN 02467976
Status: Marketed
Holder: JUNO PHARMA CANADA INC.
Available to quote
Health Canada record
| Active ingredient(s) | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N05CM18 DEXMEDETOMIDINE |
| Original market date | 15-Jan-2019 |
| Current status date | 20-Feb-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Juno Pharma Canada Inc. — licence 3-002916, currently licensed, last inspection rating C (2025-11-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02464381 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | AURO PHARMA INC | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Marketed |
| 02477327 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | ACCORD HEALTHCARE INC | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Marketed |
| 02528886 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | EUGIA PHARMA INC. | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Marketed |
| 02537095 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION USP | HIKMA CANADA LIMITED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Approved |
| 02513978 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP | BAXTER CORPORATION | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Marketed |
| 02536463 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | FRESENIUS KABI CANADA LTD | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCG | Approved |
| 02487365 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | JUNO PHARMA CANADA INC. | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCG | Marketed |
| 02487373 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | JUNO PHARMA CANADA INC. | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400 MCG | Marketed |
| 02537109 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | HIKMA CANADA LIMITED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCG | Marketed |
| 02437147 | PRECEDEX | PFIZER CANADA ULC | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 4 MCG | Marketed |
| 02493314 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION | SANDOZ CANADA INCORPORATED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Cancelled Pre Market |
| 02539152 | DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP | OMEGA LABORATORIES LIMITED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Cancelled Pre Market |
| 02539470 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | OMEGA LABORATORIES LIMITED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 400 MCG | Cancelled Pre Market |
| 02539462 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION | OMEGA LABORATORIES LIMITED | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCG | Cancelled Pre Market |
| 02339366 | PRECEDEX | PFIZER CANADA ULC | Solution | DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100 MCG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36936 | 2026-02-20 | Abbreviated New Drug Submission (ANDS) | Administrative: Merger/Buy-out |
| 23868 | 2020-07-08 | Abbreviated New Drug Submission (ANDS) | Administrative: Manufacturer Name Change |
| 21689 | 2019-01-03 | Abbreviated New Drug Submission (ANDS) |