LABETALOL HYDROCHLORIDE INJECTION, USP DIN 02340194
Health Canada record
| Active ingredient(s) | LABETALOL HYDROCHLORIDE 5 MG |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C07AG01 LABETALOL |
| Original market date | |
| Current status date | 02-Sep-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Strides Pharma Canada Inc. — licence 3-002485, currently licensed, last inspection rating C (2026-03-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing LABETALOL HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02243539 | APO-LABETALOL | APOTEX INC | Tablet | LABETALOL HYDROCHLORIDE 200 MG | Marketed |
| 02243538 | APO-LABETALOL | APOTEX INC | Tablet | LABETALOL HYDROCHLORIDE 100 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 |
| 02541505 | LABETALOL HYDROCHLORIDE INJECTION USP | JAMP PHARMA CORPORATION | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02385120 | LABETALOL HYDROCHLORIDE INJECTION USP | STERIMAX INC | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 02231689 | LABETALOL HYDROCHLORIDE INJECTION USP | SANDOZ CANADA INCORPORATED | Solution | LABETALOL HYDROCHLORIDE 5 MG | Marketed |
| 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 |
| 02106280 | TRANDATE | KNIGHT THERAPEUTICS INC. | Tablet | LABETALOL HYDROCHLORIDE 200 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 |
|---|---|---|---|
| 26584 | 2021-09-02 | Abbreviated New Drug Submission (ANDS) | Administrative: Change in Product Ownership |
| 16344 | 2014-11-21 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 13199 | 2012-04-12 | Abbreviated New Drug Submission (ANDS) | Manufacturer name change |
| 12118 | 2011-02-25 | Abbreviated New Drug Submission (ANDS) | Manufacturer name change |
| 10895 | 2009-12-30 | Abbreviated New Drug Submission (ANDS) |
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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