MIDAZOLAM INJECTION DIN 02383594
Status: Cancelled Pre Market
Holder: MYLAN PHARMACEUTICALS ULC
Molecule: MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
Health Canada record
| Active ingredient(s) | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG |
|---|---|
| Dosage form | Solution |
| Route | Intramuscular; Intravenous |
| Schedule | TARGETED SUBSTANCES (CDSA IV) |
| Class | Human |
| ATC | N05CD08 MIDAZOLAM |
| Original market date | |
| Current status date | 09-May-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02559609 | BUCCOLAM | NEURAXPHARM PHARMACEUTICALS, S.L. | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 10 MG | Marketed |
| 02559595 | BUCCOLAM | NEURAXPHARM PHARMACEUTICALS, S.L. | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 7.5 MG | Marketed |
| 02559587 | BUCCOLAM | NEURAXPHARM PHARMACEUTICALS, S.L. | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Marketed |
| 02559579 | BUCCOLAM | NEURAXPHARM PHARMACEUTICALS, S.L. | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 2.5 MG | Marketed |
| 02243253 | APO-MIDAZOLAM INJECTABLE 1 MG/ML | APOTEX INC | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 02243254 | APO-MIDAZOLAM INJECTABLE 5 MG/ML | APOTEX INC | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Cancelled Post Market |
| 02243934 | MIDAZOLAM INJECTION | NOVOPHARM LIMITED | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 02243935 | MIDAZOLAM INJECTION | NOVOPHARM LIMITED | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Cancelled Post Market |
| 02383586 | MIDAZOLAM INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Pre Market |
| 02241753 | MIDAZOLAM INJECTION BP | HOSPIRA HEALTHCARE ULC | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Pre Market |
| 02241754 | MIDAZOLAM INJECTION BP | HOSPIRA HEALTHCARE ULC | Solution | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Cancelled Pre Market |
| 02242654 | PMS-MIDAZOLAM | PHARMASCIENCE INC | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Cancelled Pre Market |
| 02242653 | PMS-MIDAZOLAM | PHARMASCIENCE INC | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Pre Market |
| 00784516 | VERSED INJ 1MG/ML | HOFFMANN-LA ROCHE LIMITED | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1 MG | Cancelled Post Market |
| 00766011 | VERSED INJ 5MG/ML | HOFFMANN-LA ROCHE LIMITED | Liquid | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 15868 | 2014-07-23 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 13215 | 2012-04-23 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |