AG-CANDESARTAN HCT DIN 02500760
Health Canada record
| Active ingredient(s) | CANDESARTAN CILEXETIL 32 MG; HYDROCHLOROTHIAZIDE 25 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C09DA06 CANDERSARTAN AND DIURETICS |
| Original market date | |
| Current status date | 22-Jun-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Angita Pharma Inc. — licence 101870, currently licensed, last inspection rating C (2025-01-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CANDESARTAN CILEXETIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02379279 | ACH-CANDESARTAN | ACCORD HEALTHCARE INC | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02379295 | ACH-CANDESARTAN | ACCORD HEALTHCARE INC | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02379287 | ACH-CANDESARTAN | ACCORD HEALTHCARE INC | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02239092 | ATACAND | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02311658 | ATACAND | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02239091 | ATACAND | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02239090 | ATACAND | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 4 MG | Marketed |
| 02332922 | ATACAND PLUS | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 32 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02244021 | ATACAND PLUS | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 16 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02332957 | ATACAND PLUS | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CANDESARTAN CILEXETIL 32 MG; HYDROCHLOROTHIAZIDE 25 MG | Marketed |
| 02377942 | CANDESARTAN | PRO DOC LIMITEE | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02388715 | CANDESARTAN | SIVEM PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02388707 | CANDESARTAN | SIVEM PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02377934 | CANDESARTAN | PRO DOC LIMITEE | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02386534 | JAMP-CANDESARTAN | JAMP PHARMA CORPORATION | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02386518 | JAMP-CANDESARTAN | JAMP PHARMA CORPORATION | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02386526 | JAMP-CANDESARTAN | JAMP PHARMA CORPORATION | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02391198 | PMS-CANDESARTAN | PHARMASCIENCE INC | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02391171 | PMS-CANDESARTAN | PHARMASCIENCE INC | Tablet | CANDESARTAN CILEXETIL 4 MG | Marketed |
| 02391228 | PMS-CANDESARTAN | PHARMASCIENCE INC | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02391201 | PMS-CANDESARTAN | PHARMASCIENCE INC | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02391295 | PMS-CANDESARTAN-HCTZ | PHARMASCIENCE INC | Tablet | CANDESARTAN CILEXETIL 16.0 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02326973 | SANDOZ CANDESARTAN | SANDOZ CANADA INCORPORATED | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02326957 | SANDOZ CANDESARTAN | SANDOZ CANADA INCORPORATED | Tablet | CANDESARTAN CILEXETIL 4 MG | Marketed |
| 02326965 | SANDOZ CANDESARTAN | SANDOZ CANADA INCORPORATED | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02327902 | SANDOZ CANDESARTAN PLUS | SANDOZ CANADA INCORPORATED | Tablet | CANDESARTAN CILEXETIL 16 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Marketed |
| 02380692 | TARO-CANDESARTAN | SUN PHARMA CANADA INC | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02380684 | TARO-CANDESARTAN | SUN PHARMA CANADA INC | Tablet | CANDESARTAN CILEXETIL 4 MG | Marketed |
| 02380714 | TARO-CANDESARTAN | SUN PHARMA CANADA INC | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02380706 | TARO-CANDESARTAN | SUN PHARMA CANADA INC | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02366320 | TEVA-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 16 MG | Marketed |
| 02366312 | TEVA-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 8 MG | Marketed |
| 02366339 | TEVA-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 32 MG | Marketed |
| 02379260 | ACH-CANDESARTAN | ACCORD HEALTHCARE INC | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Post Market |
| 02376555 | ACT CANDESARTAN | ACTAVIS PHARMA COMPANY | Tablet | CANDESARTAN CILEXETIL 32 MG | Cancelled Post Market |
| 02376547 | ACT CANDESARTAN | ACTAVIS PHARMA COMPANY | Tablet | CANDESARTAN CILEXETIL 16 MG | Cancelled Post Market |
| 02376520 | ACT CANDESARTAN | ACTAVIS PHARMA COMPANY | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Post Market |
| 02376539 | ACT CANDESARTAN | ACTAVIS PHARMA COMPANY | Tablet | CANDESARTAN CILEXETIL 8 MG | Cancelled Post Market |
| 02388650 | ACT CANDESARTAN/HCT | ACTAVIS PHARMA COMPANY | Tablet | CANDESARTAN CILEXETIL 16 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02365367 | APO-CANDESARTAN | APOTEX INC | Tablet | CANDESARTAN CILEXETIL 16 MG | Dormant |
| 02365359 | APO-CANDESARTAN | APOTEX INC | Tablet | CANDESARTAN CILEXETIL 8 MG | Dormant |
| 02365340 | APO-CANDESARTAN | APOTEX INC | Tablet | CANDESARTAN CILEXETIL 4 MG | Dormant |
| 02367866 | APO-CANDESARTAN/HCTZ | APOTEX INC | Tablet | CANDESARTAN CILEXETIL 16.0 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Dormant |
| 02388901 | CANDESARTAN | SANIS HEALTH INC | Tablet | CANDESARTAN CILEXETIL 4 MG | Dormant |
| 02388693 | CANDESARTAN | SIVEM PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Post Market |
| 02388936 | CANDESARTAN | SANIS HEALTH INC | Tablet | CANDESARTAN CILEXETIL 16 MG | Dormant |
| 02388928 | CANDESARTAN | SANIS HEALTH INC | Tablet | CANDESARTAN CILEXETIL 8 MG | Dormant |
| 02386496 | JAMP-CANDESARTAN | JAMP PHARMA CORPORATION | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Post Market |
| 02379120 | MYLAN-CANDESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Post Market |
| 02379139 | MYLAN-CANDESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 8 MG | Cancelled Post Market |
| 02379147 | MYLAN-CANDESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 16 MG | Cancelled Post Market |
| 02379155 | MYLAN-CANDESARTAN | MYLAN PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 32 MG | Cancelled Post Market |
| 02374897 | MYLAN-CANDESARTAN HCTZ | MYLAN PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 16.0 MG; HYDROCHLOROTHIAZIDE 12.5 MG | Cancelled Post Market |
| 02384949 | NTP-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 8 MG | Cancelled Pre Market |
| 02384965 | NTP-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 32 MG | Cancelled Pre Market |
| 02384957 | NTP-CANDESARTAN | TEVA CANADA LIMITED | Tablet | CANDESARTAN CILEXETIL 16 MG | Cancelled Pre Market |
| 02390612 | Q-CANDESARTAN | QD PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 16 MG | Cancelled Pre Market |
| 02390604 | Q-CANDESARTAN | QD PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 8 MG | Cancelled Pre Market |
| 02390620 | Q-CANDESARTAN | QD PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 32 MG | Cancelled Pre Market |
| 02390590 | Q-CANDESARTAN | QD PHARMACEUTICALS ULC | Tablet | CANDESARTAN CILEXETIL 4 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23828 | 2020-06-22 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Companies |
International API supply for CANDESARTAN CILEXETIL
10 valid EDQM Certificates of Suitability from 10 holders. 12 active FDA Drug Master Files.
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