RAN-IRBESARTAN HCTZ DIN 02363208
Health Canada record
| Active ingredient(s) | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C09DA04 IRBESARTAN AND DIURETICS |
| Original market date | 01-Apr-2011 |
| Current status date | 12-Jul-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Ranbaxy Pharmaceuticals Canada Inc. (a SUN PHARMA Company) — licence 101281, not currently licensed, last inspection rating C (2022-02-01).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing IRBESARTAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02241818 | AVALIDE | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02241819 | AVALIDE | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02237924 | AVAPRO | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 150 MG | Marketed |
| 02237925 | AVAPRO | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 300 MG | Marketed |
| 02372347 | IRBESARTAN | SANIS HEALTH INC | Tablet | IRBESARTAN 75 MG | Marketed |
| 02317087 | PMS-IRBESARTAN | PHARMASCIENCE INC | Tablet | IRBESARTAN 300 MG | Marketed |
| 02317060 | PMS-IRBESARTAN | PHARMASCIENCE INC | Tablet | IRBESARTAN 75 MG | Marketed |
| 02317079 | PMS-IRBESARTAN | PHARMASCIENCE INC | Tablet | IRBESARTAN 150 MG | Marketed |
| 02328518 | PMS-IRBESARTAN-HCTZ | PHARMASCIENCE INC | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02328534 | PMS-IRBESARTAN-HCTZ | PHARMASCIENCE INC | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02328526 | PMS-IRBESARTAN-HCTZ | PHARMASCIENCE INC | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02365197 | PRO-IRBESARTAN | PRO DOC LIMITEE | Tablet | IRBESARTAN 75 MG | Marketed |
| 02365219 | PRO-IRBESARTAN | PRO DOC LIMITEE | Tablet | IRBESARTAN 300 MG | Marketed |
| 02365200 | PRO-IRBESARTAN | PRO DOC LIMITEE | Tablet | IRBESARTAN 150 MG | Marketed |
| 02365170 | PRO-IRBESARTAN-HCTZ | PRO DOC LIMITEE | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02365189 | PRO-IRBESARTAN-HCTZ | PRO DOC LIMITEE | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02365162 | PRO-IRBESARTAN-HCTZ | PRO DOC LIMITEE | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02328488 | SANDOZ IRBESARTAN | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 150 MG | Marketed |
| 02328496 | SANDOZ IRBESARTAN | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 300 MG | Marketed |
| 02328461 | SANDOZ IRBESARTAN | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 75 MG | Marketed |
| 02337428 | SANDOZ IRBESARTAN HCT | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02337436 | SANDOZ IRBESARTAN HCT | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02337444 | SANDOZ IRBESARTAN HCT | SANDOZ CANADA INCORPORATED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02330512 | TEVA-IRBESARTAN HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02330539 | TEVA-IRBESARTAN HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02330520 | TEVA-IRBESARTAN HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02328070 | ACT IRBESARTAN | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 75 MG | Cancelled Post Market |
| 02328100 | ACT IRBESARTAN | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 300 MG | Cancelled Post Market |
| 02328089 | ACT IRBESARTAN | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 150 MG | Cancelled Post Market |
| 02357410 | ACT IRBESARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02357402 | ACT IRBESARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02357399 | ACT IRBESARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02280213 | AVALIDE | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02237923 | AVAPRO | SANOFI-AVENTIS CANADA INC | Tablet | IRBESARTAN 75 MG | Cancelled Post Market |
| 02372207 | DOM-IRBESARTAN | DOMINION PHARMACAL | Tablet | IRBESARTAN 300 MG | Cancelled Pre Market |
| 02372185 | DOM-IRBESARTAN | DOMINION PHARMACAL | Tablet | IRBESARTAN 75 MG | Cancelled Pre Market |
| 02372193 | DOM-IRBESARTAN | DOMINION PHARMACAL | Tablet | IRBESARTAN 150 MG | Cancelled Post Market |
| 02372266 | DOM-IRBESARTAN-HCTZ | DOMINION PHARMACAL | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Pre Market |
| 02372223 | DOM-IRBESARTAN-HCTZ | DOMINION PHARMACAL | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Pre Market |
| 02372231 | DOM-IRBESARTAN-HCTZ | DOMINION PHARMACAL | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Pre Market |
| 02347326 | MYLAN-IRBESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | IRBESARTAN 300 MG | Cancelled Post Market |
| 02347318 | MYLAN-IRBESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | IRBESARTAN 150 MG | Cancelled Post Market |
| 02347296 | MYLAN-IRBESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | IRBESARTAN 75 MG | Cancelled Post Market |
| 02368986 | NTP-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG | Cancelled Pre Market |
| 02368994 | NTP-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG | Cancelled Pre Market |
| 02368978 | NTP-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 75 MG | Cancelled Pre Market |
| 02368935 | NTP-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Pre Market |
| 02368943 | NTP-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Pre Market |
| 02368951 | NTP-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Pre Market |
| 02363216 | RAN-IRBESARTAN HCTZ | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02363224 | RAN-IRBESARTAN HCTZ | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02316404 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG | Cancelled Post Market |
| 02316005 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG | Cancelled Post Market |
| 02315998 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG | Cancelled Post Market |
| 02315971 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 75 MG | Cancelled Post Market |
| 02316390 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 75 MG | Cancelled Post Market |
| 02316412 | TEVA-IRBESARTAN | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG | Cancelled Post Market |
| 02316048 | TEVA-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 25 MG | Cancelled Post Market |
| 02316013 | TEVA-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 150 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02316021 | TEVA-IRBESARTAN/HCTZ | TEVA CANADA LIMITED | Tablet | IRBESARTAN 300 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12228 | 2011-03-30 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for IRBESARTAN
17 valid EDQM Certificates of Suitability from 16 holders. 24 active FDA Drug Master Files.
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