MIDAZOLAM INJECTION USP DIN 02498022
Health Canada record
| Active ingredient(s) | MIDAZOLAM 1 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| Class | Human |
| ATC | N05CD08 MIDAZOLAM |
| Original market date | 26-Oct-2020 |
| Current status date | 26-Oct-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sterinova Inc — licence 102212, currently licensed, last inspection rating I (2026-04-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MIDAZOLAM
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02517582 | DORMAZOLAM | DECHRA REGULATORY BV | Solution | MIDAZOLAM 5 MG | Marketed |
| 02240285 | MIDAZOLAM INJECTION | SANDOZ CANADA INCORPORATED | Solution | MIDAZOLAM 1 MG | Marketed |
| 02240286 | MIDAZOLAM INJECTION | SANDOZ CANADA INCORPORATED | Solution | MIDAZOLAM 5 MG | Marketed |
| 02382377 | MIDAZOLAM INJECTION USP | PFIZER CANADA ULC | Solution | MIDAZOLAM 1 MG | Marketed |
| 02382385 | MIDAZOLAM INJECTION USP | PFIZER CANADA ULC | Solution | MIDAZOLAM 5 MG | Marketed |
| 02553104 | MIDAZOLAM INJECTION USP | HIKMA CANADA LIMITED | Solution | MIDAZOLAM 1 MG | Marketed |
| 02382342 | MIDAZOLAM INJECTION USP | PFIZER CANADA ULC | Solution | MIDAZOLAM 1 MG | Marketed |
| 02382350 | MIDAZOLAM INJECTION USP | PFIZER CANADA ULC | Solution | MIDAZOLAM 5 MG | Marketed |
| 02242904 | MIDAZOLAM INJECTION, USP | FRESENIUS KABI CANADA LTD | Solution | MIDAZOLAM 1 MG | Marketed |
| 02242905 | MIDAZOLAM INJECTION, USP | FRESENIUS KABI CANADA LTD | Solution | MIDAZOLAM 5 MG | Marketed |
| 02529300 | MIDAZOLAM INJECTION, USP | BAXTER CORPORATION | Solution | MIDAZOLAM 1 MG | Approved |
| 02529319 | MIDAZOLAM INJECTION, USP | BAXTER CORPORATION | Solution | MIDAZOLAM 5 MG | Approved |
| 02423758 | MIDAZOLAM INJECTION | PFIZER CANADA ULC | Solution | MIDAZOLAM 1 MG | Cancelled Post Market |
| 02423766 | MIDAZOLAM INJECTION | PFIZER CANADA ULC | Solution | MIDAZOLAM 5 MG | Cancelled Post Market |
| 02382873 | MIDAZOLAM INJECTION SDZ | SANDOZ CANADA INCORPORATED | Solution | MIDAZOLAM 1 MG | Dormant |
| 02382903 | MIDAZOLAM INJECTION SDZ | SANDOZ CANADA INCORPORATED | Solution | MIDAZOLAM 5 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23476 | 2020-04-20 | Abbreviated New Drug Submission (ANDS) |
International API supply for MIDAZOLAM
7 valid EDQM Certificates of Suitability from 7 holders. 9 active FDA Drug Master Files.
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