MINT-VARENICLINE DIN 02546965
Status: Marketed
Holder: MINT PHARMACEUTICALS INC
Molecule: VARENICLINE (VARENICLINE TARTRATE)
Available to quote
Health Canada record
| Active ingredient(s) | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG |
|---|---|
| Dosage form | Kit; Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N07BA03 VARENICLINE |
| Original market date | 15-May-2025 |
| Current status date | 15-May-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing VARENICLINE (VARENICLINE TARTRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02419882 | APO-VARENICLINE | APOTEX INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Marketed |
| 02435675 | APO-VARENICLINE | APOTEX INC | Kit; Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02419890 | APO-VARENICLINE | APOTEX INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02554453 | AURO-VARENICLINE | AURO PHARMA INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02554445 | AURO-VARENICLINE | AURO PHARMA INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Marketed |
| 02546957 | MINT-VARENICLINE | MINT PHARMACEUTICALS INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02546949 | MINT-VARENICLINE | MINT PHARMACEUTICALS INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Marketed |
| 02542986 | NRA-VARENICLINE | NORA PHARMA INC | Tablet; Kit | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02542978 | NRA-VARENICLINE | NORA PHARMA INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02542951 | NRA-VARENICLINE | NORA PHARMA INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Marketed |
| 02559897 | ZDS-VARENICLINE | ZYDUS LIFESCIENCES LIMITED | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Marketed |
| 02559900 | ZDS-VARENICLINE | ZYDUS LIFESCIENCES LIMITED | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Marketed |
| 02291177 | CHAMPIX | PFIZER CANADA ULC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Cancelled Post Market |
| 02291185 | CHAMPIX | PFIZER CANADA ULC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Post Market |
| 02298309 | CHAMPIX | PFIZER CANADA ULC | Tablet; Kit | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Post Market |
| 02438445 | GD-VARENICLINE | GENMED A DIVISION OF PFIZER CANADA ULC | Kit; Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Pre Market |
| 02438437 | GD-VARENICLINE | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Pre Market |
| 02438429 | GD-VARENICLINE | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Cancelled Pre Market |
| 02485869 | PMS-VARENICLINE | PHARMASCIENCE INC | Kit; Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Pre Market |
| 02458519 | PMS-VARENICLINE | PHARMASCIENCE INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Pre Market |
| 02458500 | PMS-VARENICLINE | PHARMASCIENCE INC | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Cancelled Pre Market |
| 02426781 | TEVA-VARENICLINE | TEVA CANADA LIMITED | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MG | Cancelled Post Market |
| 02426234 | TEVA-VARENICLINE | TEVA CANADA LIMITED | Tablet | VARENICLINE (VARENICLINE TARTRATE) 1 MG | Dormant |
| 02426226 | TEVA-VARENICLINE | TEVA CANADA LIMITED | Tablet | VARENICLINE (VARENICLINE TARTRATE) 0.5 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33033 | 2024-04-10 | Abbreviated New Drug Submission (ANDS) |