BISOPROLOL DIN 02391589
Health Canada record
| Active ingredient(s) | BISOPROLOL FUMARATE 5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C07AB07 BISOPROLOL |
| Original market date | 01-Oct-2012 |
| Current status date | 27-Aug-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sanis Health Inc. — licence 101796, currently licensed, last inspection rating I (2024-07-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BISOPROLOL FUMARATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02521164 | AG-BISOPROLOL | ANGITA PHARMA INC. | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02521156 | AG-BISOPROLOL | ANGITA PHARMA INC. | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02256177 | APO-BISOPROLOL | APOTEX INC | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02256134 | APO-BISOPROLOL | APOTEX INC | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02391597 | BISOPROLOL | SANIS HEALTH INC | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02554240 | BISOPROLOL TABLETS | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 1.25 MG | Approved |
| 02495562 | BISOPROLOL TABLETS | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02495570 | BISOPROLOL TABLETS | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02554259 | BISOPROLOL TABLETS | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 2.5 MG | Approved |
| 02518805 | JAMP BISOPROLOL | JAMP PHARMA CORPORATION | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02518791 | JAMP BISOPROLOL | JAMP PHARMA CORPORATION | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02562278 | M-BISOPROLOL | MANTRA PHARMA INC | Tablet | BISOPROLOL FUMARATE 10 MG | Approved |
| 02562251 | M-BISOPROLOL | MANTRA PHARMA INC | Tablet | BISOPROLOL FUMARATE 5 MG | Approved |
| 02465612 | MINT-BISOPROLOL | MINT PHARMACEUTICALS INC | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02465620 | MINT-BISOPROLOL | MINT PHARMACEUTICALS INC | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02558564 | NB-BISOPROLOL TABLETS | NB PHARMA INC. | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02558521 | NB-BISOPROLOL TABLETS | NB PHARMA INC. | Tablet | BISOPROLOL FUMARATE 1.25 MG | Approved |
| 02558548 | NB-BISOPROLOL TABLETS | NB PHARMA INC. | Tablet | BISOPROLOL FUMARATE 2.5 MG | Approved |
| 02558556 | NB-BISOPROLOL TABLETS | NB PHARMA INC. | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02307006 | PRO-BISOPROLOL | PRO DOC LIMITEE | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02306999 | PRO-BISOPROLOL | PRO DOC LIMITEE | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02541394 | PRZ-BISOPROLOL | PHARMARIS CANADA INC | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02541408 | PRZ-BISOPROLOL | PHARMARIS CANADA INC | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02494043 | SANDOZ BISOPROLOL TABLETS | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02494035 | SANDOZ BISOPROLOL TABLETS | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02544245 | SANDOZ BISOPROLOL TABLETS | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 1.25 MG | Marketed |
| 02544253 | SANDOZ BISOPROLOL TABLETS | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 2.5 MG | Marketed |
| 02267470 | TEVA-BISOPROLOL | TEVA CANADA LIMITED | Tablet | BISOPROLOL FUMARATE 5 MG | Marketed |
| 02267489 | TEVA-BISOPROLOL | TEVA CANADA LIMITED | Tablet | BISOPROLOL FUMARATE 10 MG | Marketed |
| 02363887 | AVA-BISOPROLOL | AVANSTRA INC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02363895 | AVA-BISOPROLOL | AVANSTRA INC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02383055 | BISOPROLOL | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02321572 | BISOPROLOL | SORRES PHARMA INC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02321556 | BISOPROLOL | SORRES PHARMA INC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02383063 | BISOPROLOL | SIVEM PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02496968 | BISOPROLOL FUMARATE | SANIS HEALTH INC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Pre Market |
| 02496941 | BISOPROLOL FUMARATE | SANIS HEALTH INC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Pre Market |
| 02308231 | DOM-BISOPROLOL | DOMINION PHARMACAL | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Pre Market |
| 02308223 | DOM-BISOPROLOL | DOMINION PHARMACAL | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Pre Market |
| 02241149 | MONOCOR -(10MG) | BIOVAIL PHARMACEUTICALS CANADA DIVISION OF BIOVAIL CORPORATION | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02241148 | MONOCOR -(5MG) | BIOVAIL PHARMACEUTICALS CANADA DIVISION OF BIOVAIL CORPORATION | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02384426 | MYLAN-BISOPROLOL | MYLAN PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02384418 | MYLAN-BISOPROLOL | MYLAN PHARMACEUTICALS ULC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02336324 | NU-BISOPROLOL | NU-PHARM INC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled (Unreturned Annual) |
| 02336332 | NU-BISOPROLOL | NU-PHARM INC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled (Unreturned Annual) |
| 02308347 | PHL-BISOPROLOL | PHARMEL INC | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02308339 | PHL-BISOPROLOL | PHARMEL INC | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02302632 | PMS-BISOPROLOL | PHARMASCIENCE INC | Tablet | BISOPROLOL FUMARATE 5 MG | Dormant |
| 02302640 | PMS-BISOPROLOL | PHARMASCIENCE INC | Tablet | BISOPROLOL FUMARATE 10 MG | Dormant |
| 02471272 | RIVA-BISOPROLOL | LABORATOIRE RIVA INC. | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02471264 | RIVA-BISOPROLOL | LABORATOIRE RIVA INC. | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
| 02247440 | SANDOZ BISOPROLOL | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 10 MG | Cancelled Post Market |
| 02247439 | SANDOZ BISOPROLOL | SANDOZ CANADA INCORPORATED | Tablet | BISOPROLOL FUMARATE 5 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23695 | 2020-05-28 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Companies. |
| 13566 | 2012-08-16 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for BISOPROLOL FUMARATE
17 valid EDQM Certificates of Suitability from 17 holders. 12 active FDA Drug Master Files.
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