TRANDATE DIN 02106280
Health Canada record
| Active ingredient(s) | LABETALOL HYDROCHLORIDE 200 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C07AG01 LABETALOL |
| Original market date | 30-Dec-1996 |
| Current status date | 29-Dec-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Knight Therapeutics Inc. — licence 3-002350, currently licensed, last inspection rating C (2025-11-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LABETALOL HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02243538 | APO-LABETALOL | APOTEX INC | Tablet | LABETALOL HYDROCHLORIDE 100 MG | Marketed |
| 02243539 | APO-LABETALOL | APOTEX INC | Tablet | LABETALOL HYDROCHLORIDE 200 MG | Marketed |
| 02457040 | LABETALOL HYDROCHLORIDE INJECTION | OMEGA LABORATORIES LIMITED | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02557037 | LABETALOL HYDROCHLORIDE INJECTION IN 0.72% SODIUM CHLORIDE | HIKMA CANADA LIMITED | Solution | LABETALOL HYDROCHLORIDE 1 MG | Approved |
| 02557029 | LABETALOL HYDROCHLORIDE INJECTION IN 5% DEXTROSE | HIKMA CANADA LIMITED | Solution | LABETALOL HYDROCHLORIDE 1 MG | Approved |
| 02385120 | LABETALOL HYDROCHLORIDE INJECTION USP | STERIMAX INC | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02541505 | LABETALOL HYDROCHLORIDE INJECTION USP | JAMP PHARMA CORPORATION | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02231689 | LABETALOL HYDROCHLORIDE INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02340194 | LABETALOL HYDROCHLORIDE INJECTION, USP | STRIDES PHARMA CANADA INC | Solution | LABETALOL HYDROCHLORIDE 5 MG | Approved |
| 02503255 | MINT-LABETALOL | MINT PHARMACEUTICALS INC | Tablet | LABETALOL HYDROCHLORIDE 100 MG | Approved |
| 02503263 | MINT-LABETALOL | MINT PHARMACEUTICALS INC | Tablet | LABETALOL HYDROCHLORIDE 200 MG | Approved |
| 02489406 | RIVA-LABETALOL | LABORATOIRE RIVA INC. | Tablet | LABETALOL HYDROCHLORIDE 100 MG | Marketed |
| 02489414 | RIVA-LABETALOL | LABORATOIRE RIVA INC. | Tablet | LABETALOL HYDROCHLORIDE 200 MG | Marketed |
| 02106272 | TRANDATE | KNIGHT THERAPEUTICS INC. | Tablet | LABETALOL HYDROCHLORIDE 100 MG | Marketed |
| 02539101 | LABETALOL HYDROCHLORIDE INJECTION | JUNO PHARMACEUTICALS CORP. | Solution | LABETALOL HYDROCHLORIDE 5 MG | Cancelled Pre Market |
| 02391090 | LABETALOL HYDROCHLORIDE INJECTION USP | PFIZER CANADA ULC | Solution | LABETALOL HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02387468 | LABETALOL HYDROCHLORIDE INJECTION, USP | MYLAN PHARMACEUTICALS ULC | Solution | LABETALOL HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 02091518 | TRANDATE 5MG/ML | SHIRE BIOCHEM INC | Liquid | LABETALOL HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 01924923 | TRANDATE INJ 5MG/ML | GLAXO CANADA INC | Liquid | LABETALOL HYDROCHLORIDE 5 MG | Cancelled Post Market |
| 01924915 | TRANDATE TAB 100MG | GLAXO CANADA INC | Tablet | LABETALOL HYDROCHLORIDE 100 MG | Cancelled Post Market |
| 01924931 | TRANDATE TAB 200MG | GLAXO CANADA INC | Tablet | LABETALOL HYDROCHLORIDE 200 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36649 | 2025-12-29 | New Drug Submission (NDS) | Administrative: Change in product ownership |
| 35427 | 2025-05-23 | New Drug Submission (NDS) | Administrative: Change in product ownership. Product Monograph reformatted to the Master Template |
| 10502 | 2009-08-13 | New Drug Submission (NDS) | Manufacturer name change |
| 8915 | 2007-07-18 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 1710 | 2003-08-01 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 1263 | 2000-03-09 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for LABETALOL HYDROCHLORIDE
5 valid EDQM Certificates of Suitability from 5 holders. 13 active FDA Drug Master Files.
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