MYLAN-BOSENTAN DIN 02383500
Status: Cancelled Post Market
Holder: MYLAN PHARMACEUTICALS ULC
Molecule: BOSENTAN (BOSENTAN MONOHYDRATE)
Health Canada record
| Active ingredient(s) | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02KX01 BOSENTAN |
| Original market date | 29-May-2012 |
| Current status date | 12-Jul-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BOSENTAN (BOSENTAN MONOHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02423065 | ALEMBIC-BOSENTAN | ALEMBIC PHARMACEUTICALS LIMITED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Approved |
| 02423057 | ALEMBIC-BOSENTAN | ALEMBIC PHARMACEUTICALS LIMITED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Approved |
| 02526409 | AURO-BOSENTAN | AURO PHARMA INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Approved |
| 02526395 | AURO-BOSENTAN | AURO PHARMA INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Approved |
| 02383012 | PMS-BOSENTAN | PHARMASCIENCE INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Marketed |
| 02383020 | PMS-BOSENTAN | PHARMASCIENCE INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Marketed |
| 02483130 | TARO-BOSENTAN | TARO PHARMACEUTICALS INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Marketed |
| 02483149 | TARO-BOSENTAN | TARO PHARMACEUTICALS INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Marketed |
| 02244981 | TRACLEER | JANSSEN INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Marketed |
| 02244982 | TRACLEER | JANSSEN INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Marketed |
| 02435403 | ACCEL-BOSENTAN | ACCEL PHARMA INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Pre Market |
| 02386194 | ACT BOSENTAN | ACTAVIS PHARMA COMPANY | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Post Market |
| 02386208 | ACT BOSENTAN | ACTAVIS PHARMA COMPANY | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Post Market |
| 02399202 | APO-BOSENTAN | APOTEX INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Dormant |
| 02399210 | APO-BOSENTAN | APOTEX INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Dormant |
| 02466538 | BIO-BOSENTAN | BIOMED PHARMA | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Post Market |
| 02466546 | BIO-BOSENTAN | BIOMED PHARMA | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Post Market |
| 02468522 | BOSENTAN | PANDA PHARMACEUTICALS INC. | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Pre Market |
| 02463555 | BOSENTAN | ACTELION PHARMACEUTICALS LTD | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Pre Market |
| 02463563 | BOSENTAN | ACTELION PHARMACEUTICALS LTD | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Pre Market |
| 02468530 | BOSENTAN | PANDA PHARMACEUTICALS INC. | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Pre Market |
| 02426463 | BOSENTAN TABLETS | ACCORD HEALTHCARE INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Post Market |
| 02424045 | MAR-BOSENTAN | MARCAN PHARMACEUTICALS INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Pre Market |
| 02424037 | MAR-BOSENTAN | MARCAN PHARMACEUTICALS INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Pre Market |
| 02383497 | MYLAN-BOSENTAN | MYLAN PHARMACEUTICALS ULC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Post Market |
| 02467992 | NAT-BOSENTAN | NATCO PHARMA (CANADA) INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Dormant |
| 02467984 | NAT-BOSENTAN | NATCO PHARMA (CANADA) INC | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Dormant |
| 02386275 | SANDOZ BOSENTAN | SANDOZ CANADA INCORPORATED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Post Market |
| 02386283 | SANDOZ BOSENTAN | SANDOZ CANADA INCORPORATED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG | Cancelled Post Market |
| 02398400 | TEVA-BOSENTAN | TEVA CANADA LIMITED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG | Cancelled Post Market |
| 02398419 | TEVA-BOSENTAN | TEVA CANADA LIMITED | Tablet | BOSENTAN (BOSENTAN MONOHYDRATE) 125.0 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 13320 | 2012-05-29 | Abbreviated New Drug Submission (ANDS) |