APO-TRANDOLAPRIL DIN 02487217
Health Canada record
| Active ingredient(s) | TRANDOLAPRIL 4 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C09AA10 TRANDOLAPRIL |
| Original market date | |
| Current status date | 08-Apr-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TRANDOLAPRIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02487209 | APO-TRANDOLAPRIL | APOTEX INC | Capsule | TRANDOLAPRIL 2 MG | Approved |
| 02487187 | APO-TRANDOLAPRIL | APOTEX INC | Capsule | TRANDOLAPRIL 0.5 MG | Approved |
| 02487195 | APO-TRANDOLAPRIL | APOTEX INC | Capsule | TRANDOLAPRIL 1 MG | Approved |
| 02471868 | AURO-TRANDOLAPRIL | AURO PHARMA INC | Capsule | TRANDOLAPRIL 0.5 MG | Marketed |
| 02471892 | AURO-TRANDOLAPRIL | AURO PHARMA INC | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02471884 | AURO-TRANDOLAPRIL | AURO PHARMA INC | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02471876 | AURO-TRANDOLAPRIL | AURO PHARMA INC | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02231459 | MAVIK | BGP PHARMA ULC | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02231457 | MAVIK | BGP PHARMA ULC | Capsule | TRANDOLAPRIL 0.5 MG | Marketed |
| 02239267 | MAVIK | BGP PHARMA ULC | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02231460 | MAVIK | BGP PHARMA ULC | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02357798 | PMS-TRANDOLAPRIL | PHARMASCIENCE INC | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02357755 | PMS-TRANDOLAPRIL | PHARMASCIENCE INC | Capsule | TRANDOLAPRIL 0.5 MG | Marketed |
| 02357763 | PMS-TRANDOLAPRIL | PHARMASCIENCE INC | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02357771 | PMS-TRANDOLAPRIL | PHARMASCIENCE INC | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02325756 | SANDOZ TRANDOLAPRIL | SANDOZ CANADA INCORPORATED | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02325721 | SANDOZ TRANDOLAPRIL | SANDOZ CANADA INCORPORATED | Capsule | TRANDOLAPRIL 0.5 MG | Marketed |
| 02325748 | SANDOZ TRANDOLAPRIL | SANDOZ CANADA INCORPORATED | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02325764 | SANDOZ TRANDOLAPRIL | SANDOZ CANADA INCORPORATED | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02526581 | TRANDOLAPRIL | SIVEM PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02488671 | TRANDOLAPRIL | PRO DOC LIMITEE | Capsule | TRANDOLAPRIL 0.5 MG | Approved |
| 02488698 | TRANDOLAPRIL | PRO DOC LIMITEE | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02488701 | TRANDOLAPRIL | PRO DOC LIMITEE | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02488728 | TRANDOLAPRIL | PRO DOC LIMITEE | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02525038 | TRANDOLAPRIL | SANIS HEALTH INC | Capsule | TRANDOLAPRIL 0.5 MG | Approved |
| 02525046 | TRANDOLAPRIL | SANIS HEALTH INC | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02525054 | TRANDOLAPRIL | SANIS HEALTH INC | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02525070 | TRANDOLAPRIL | SANIS HEALTH INC | Capsule | TRANDOLAPRIL 4 MG | Marketed |
| 02526565 | TRANDOLAPRIL | SIVEM PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 1 MG | Marketed |
| 02526573 | TRANDOLAPRIL | SIVEM PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 2 MG | Marketed |
| 02471752 | MYLAN-TRANDOLAPRIL | MYLAN PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 0.5 MG | Cancelled Pre Market |
| 02471760 | MYLAN-TRANDOLAPRIL | MYLAN PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 1 MG | Cancelled Pre Market |
| 02471779 | MYLAN-TRANDOLAPRIL | MYLAN PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 2 MG | Cancelled Pre Market |
| 02471787 | MYLAN-TRANDOLAPRIL | MYLAN PHARMACEUTICALS ULC | Capsule | TRANDOLAPRIL 4 MG | Cancelled Pre Market |
| 02240946 | TARKA | BGP PHARMA ULC | Tablet (Extended-Release) | TRANDOLAPRIL 2 MG; VERAPAMIL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 02238097 | TARKA | BGP PHARMA ULC | Tablet (Extended-Release) | TRANDOLAPRIL 4 MG; VERAPAMIL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 02238096 | TARKA | ABBOTT LABORATORIES, LIMITED | Tablet (Extended-Release) | TRANDOLAPRIL 2 MG; VERAPAMIL HYDROCHLORIDE 180 MG | Cancelled Post Market |
| 02240945 | TARKA | ABBOTT LABORATORIES, LIMITED | Tablet (Extended-Release) | TRANDOLAPRIL 1 MG; VERAPAMIL HYDROCHLORIDE 240 MG | Cancelled Post Market |
| 02415445 | TEVA-TRANDOLAPRIL | TEVA CANADA LIMITED | Capsule | TRANDOLAPRIL 2 MG | Cancelled Post Market |
| 02415437 | TEVA-TRANDOLAPRIL | TEVA CANADA LIMITED | Capsule | TRANDOLAPRIL 1 MG | Cancelled Post Market |
| 02415429 | TEVA-TRANDOLAPRIL | TEVA CANADA LIMITED | Capsule | TRANDOLAPRIL 0.5 MG | Cancelled Post Market |
| 02415453 | TEVA-TRANDOLAPRIL | TEVA CANADA LIMITED | Capsule | TRANDOLAPRIL 4 MG | Cancelled Post Market |
| 02384507 | TRANDOLAPRIL | LABORATOIRE RIVA INC. | Capsule | TRANDOLAPRIL 2 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22042 | 2019-04-08 | Abbreviated New Drug Submission (ANDS) |
International API supply for TRANDOLAPRIL
4 valid EDQM Certificates of Suitability from 3 holders. 3 active FDA Drug Master Files.
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