OPSUMIT DIN 02415690
Health Canada record
| Active ingredient(s) | MACITENTAN 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02KX04 MACITENTAN |
| Original market date | 15-Jan-2014 |
| Current status date | 09-Sep-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MACITENTAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02561069 | OPSUMIT | JANSSEN INC | Tablet For Suspension | MACITENTAN 2.5 MG | Marketed |
| 02521083 | OPSYNVI | JANSSEN INC | Tablet | MACITENTAN 10 MG; TADALAFIL 40 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 21572 | 2018-11-28 | New Drug Submission (NDS) | MERGER - BUYOUT |
| 14884 | 2013-11-06 | New Drug Submission (NDS) |
International API supply for MACITENTAN
14 active FDA Drug Master Files.
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