AURO-AMBRISENTAN DIN 02527103
Health Canada record
| Active ingredient(s) | AMBRISENTAN 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02KX02 AMBRISENTAN |
| Original market date | |
| Current status date | 05-May-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Auro Pharma Inc — licence 101305, currently licensed, last inspection rating C (2023-09-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AMBRISENTAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02475375 | APO-AMBRISENTAN | APOTEX INC | Tablet | AMBRISENTAN 5 MG | Marketed |
| 02475383 | APO-AMBRISENTAN | APOTEX INC | Tablet | AMBRISENTAN 10 MG | Marketed |
| 02527081 | AURO-AMBRISENTAN | AURO PHARMA INC | Tablet | AMBRISENTAN 5 MG | Approved |
| 02554089 | M-AMBRISENTAN | MANTRA PHARMA INC | Tablet | AMBRISENTAN 5 MG | Approved |
| 02554097 | M-AMBRISENTAN | MANTRA PHARMA INC | Tablet | AMBRISENTAN 10 MG | Approved |
| 02307065 | VOLIBRIS | GLAXOSMITHKLINE INC | Tablet | AMBRISENTAN 5 MG | Marketed |
| 02307073 | VOLIBRIS | GLAXOSMITHKLINE INC | Tablet | AMBRISENTAN 10 MG | Marketed |
| 02521938 | JAMP AMBRISENTAN | JAMP PHARMA CORPORATION | Tablet | AMBRISENTAN 5 MG | Dormant |
| 02521946 | JAMP AMBRISENTAN | JAMP PHARMA CORPORATION | Tablet | AMBRISENTAN 10 MG | Dormant |
| 02525305 | SANDOZ AMBRISENTAN | SANDOZ CANADA INCORPORATED | Tablet | AMBRISENTAN 5 MG | Cancelled Pre Market |
| 02525313 | SANDOZ AMBRISENTAN | SANDOZ CANADA INCORPORATED | Tablet | AMBRISENTAN 10 MG | Cancelled Pre Market |
| 02526883 | SANDOZ AMBRISENTAN TABLETS | SANDOZ CANADA INCORPORATED | Tablet | AMBRISENTAN 10 MG | Cancelled Post Market |
| 02526875 | SANDOZ AMBRISENTAN TABLETS | SANDOZ CANADA INCORPORATED | Tablet | AMBRISENTAN 5 MG | Cancelled Post Market |
| 02536234 | TEVA-AMBRISENTAN | TEVA CANADA LIMITED | Tablet | AMBRISENTAN 5 MG | Cancelled Pre Market |
| 02536242 | TEVA-AMBRISENTAN | TEVA CANADA LIMITED | Tablet | AMBRISENTAN 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 28088 | 2022-05-05 | Abbreviated New Drug Submission (ANDS) |
International API supply for AMBRISENTAN
9 active FDA Drug Master Files.
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