APO-TELMISARTAN-AMLODIPINE DIN 02473453
Health Canada record
| Active ingredient(s) | TELMISARTAN 40 MG; AMLODIPINE (AMLODIPINE BESYLATE) 5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C09DB04 TELMISARTAN AND AMLODIPINE |
| Original market date | |
| Current status date | 18-Oct-2023 |
| 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 TELMISARTAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02407485 | ACH-TELMISARTAN | ACCORD HEALTHCARE INC | Tablet | TELMISARTAN 40 MG | Marketed |
| 02407493 | ACH-TELMISARTAN | ACCORD HEALTHCARE INC | Tablet | TELMISARTAN 80 MG | Marketed |
| 02419114 | ACH-TELMISARTAN HCTZ | ACCORD HEALTHCARE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02419122 | ACH-TELMISARTAN HCTZ | ACCORD HEALTHCARE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02386763 | JAMP TELMISARTAN | JAMP PHARMA CORPORATION | Tablet | TELMISARTAN 80 MG | Marketed |
| 02386755 | JAMP TELMISARTAN | JAMP PHARMA CORPORATION | Tablet | TELMISARTAN 40 MG | Marketed |
| 02389940 | JAMP TELMISARTAN-HCT | JAMP PHARMA CORPORATION | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02389959 | JAMP TELMISARTAN-HCT | JAMP PHARMA CORPORATION | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02240769 | MICARDIS 40MG TAB | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 40 MG | Marketed |
| 02240770 | MICARDIS 80MG TAB | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 80 MG | Marketed |
| 02318709 | MICARDIS PLUS | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02244344 | MICARDIS PLUS | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02427281 | PENDO-TELMISARTAN | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | TELMISARTAN 40 MG | Approved |
| 02427230 | PENDO-TELMISARTAN-HCTZ | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Approved |
| 02427249 | PENDO-TELMISARTAN-HCTZ | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Approved |
| 02395525 | PRO-TELMISARTAN-HCTZ | PRO DOC LIMITEE | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02395533 | PRO-TELMISARTAN-HCTZ | PRO DOC LIMITEE | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02375966 | SANDOZ TELMISARTAN | SANDOZ CANADA INCORPORATED | Tablet | TELMISARTAN 80 MG | Marketed |
| 02375958 | SANDOZ TELMISARTAN | SANDOZ CANADA INCORPORATED | Tablet | TELMISARTAN 40 MG | Marketed |
| 02393565 | SANDOZ TELMISARTAN HCT | SANDOZ CANADA INCORPORATED | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02393557 | SANDOZ TELMISARTAN HCT | SANDOZ CANADA INCORPORATED | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02418126 | SEMINTRA 4 MG/ML ORAL SOLUTION | BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. | Solution | TELMISARTAN 4 MG | Marketed |
| 02395231 | TELMISARTAN | PRO DOC LIMITEE | Tablet | TELMISARTAN 80 MG | Marketed |
| 02388944 | TELMISARTAN | SANIS HEALTH INC | Tablet | TELMISARTAN 40 MG | Marketed |
| 02388952 | TELMISARTAN | SANIS HEALTH INC | Tablet | TELMISARTAN 80 MG | Marketed |
| 02390345 | TELMISARTAN | SIVEM PHARMACEUTICALS ULC | Tablet | TELMISARTAN 40 MG | Marketed |
| 02390353 | TELMISARTAN | SIVEM PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG | Marketed |
| 02395223 | TELMISARTAN | PRO DOC LIMITEE | Tablet | TELMISARTAN 40 MG | Marketed |
| 02390302 | TELMISARTAN HCTZ | SIVEM PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02390310 | TELMISARTAN HCTZ | SIVEM PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02395363 | TELMISARTAN/HCTZ | SANIS HEALTH INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02395355 | TELMISARTAN/HCTZ | SANIS HEALTH INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02320185 | TEVA-TELMISARTAN | TEVA CANADA LIMITED | Tablet | TELMISARTAN 80 MG | Marketed |
| 02320177 | TEVA-TELMISARTAN | TEVA CANADA LIMITED | Tablet | TELMISARTAN 40 MG | Marketed |
| 02371049 | TWYNSTA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 80 MG; AMLODIPINE (AMLODIPINE BESYLATE) 5 MG | Marketed |
| 02371022 | TWYNSTA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 40 MG; AMLODIPINE (AMLODIPINE BESYLATE) 5 MG | Marketed |
| 02371057 | TWYNSTA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 80 MG; AMLODIPINE (AMLODIPINE BESYLATE) 10 MG | Marketed |
| 02371030 | TWYNSTA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | TELMISARTAN 40 MG; AMLODIPINE (AMLODIPINE BESYLATE) 10 MG | Marketed |
| 02393255 | ACT TELMISARTAN | ACTAVIS PHARMA COMPANY | Tablet | TELMISARTAN 80 MG | Cancelled Post Market |
| 02393247 | ACT TELMISARTAN | ACTAVIS PHARMA COMPANY | Tablet | TELMISARTAN 40 MG | Cancelled Post Market |
| 02393263 | ACT TELMISARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02393271 | ACT TELMISARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02420090 | APO-TELMISARTAN | APOTEX INC | Tablet | TELMISARTAN 80 MG | Cancelled Post Market |
| 02420082 | APO-TELMISARTAN | APOTEX INC | Tablet | TELMISARTAN 40 MG | Cancelled Post Market |
| 02420023 | APO-TELMISARTAN/HCTZ | APOTEX INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02420031 | APO-TELMISARTAN/HCTZ | APOTEX INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02376717 | MYLAN-TELMISARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | TELMISARTAN 40 MG | Cancelled Post Market |
| 02376725 | MYLAN-TELMISARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG | Cancelled Post Market |
| 02373572 | MYLAN-TELMISARTAN HCTZ | MYLAN PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02373564 | MYLAN-TELMISARTAN HCTZ | MYLAN PHARMACEUTICALS ULC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02388731 | NTP-TELMISARTAN | TEVA CANADA LIMITED | Tablet | TELMISARTAN 80 MG | Cancelled Pre Market |
| 02388723 | NTP-TELMISARTAN | TEVA CANADA LIMITED | Tablet | TELMISARTAN 40 MG | Cancelled Pre Market |
| 02391236 | PHARMA-TELMISARTAN | PHARMASCIENCE INC | Tablet | TELMISARTAN 40 MG | Dormant |
| 02391244 | PHARMA-TELMISARTAN | PHARMASCIENCE INC | Tablet | TELMISARTAN 80 MG | Dormant |
| 02401673 | PMS-TELMISARTAN-HCTZ | PHARMASCIENCE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02401665 | PMS-TELMISARTAN-HCTZ | PHARMASCIENCE INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02395428 | RAN-TELMISARTAN | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | TELMISARTAN 80 MG | Cancelled Post Market |
| 02395401 | RAN-TELMISARTAN | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | TELMISARTAN 40 MG | Cancelled Post Market |
| 02396246 | TARO-TELMISARTAN HCTZ | SUN PHARMA CANADA INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02396238 | TARO-TELMISARTAN HCTZ | SUN PHARMA CANADA INC | Tablet | TELMISARTAN 80 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 31877 | 2023-10-18 | Abbreviated New Drug Submission (ANDS) | Administrative: Change in Product Ownership. Update to the Product Monograph. Update to the Package Insert. Update to Labels |
| 24182 | 2020-09-04 | Abbreviated New Drug Submission (ANDS) | CHANGE IN PRODUCT OWNERSHIP |
| 20528 | 2018-02-27 | Abbreviated New Drug Submission (ANDS) |
International API supply for TELMISARTAN
25 valid EDQM Certificates of Suitability from 25 holders. 28 active FDA Drug Master Files.
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