XELJANZ DIN 02480786
Status: Marketed
Holder: PFIZER CANADA ULC
Molecule: TOFACITINIB (TOFACITINIB CITRATE)
Available to quote
Health Canada record
| Active ingredient(s) | TOFACITINIB (TOFACITINIB CITRATE) 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AF01 TOFACITINIB |
| Original market date | 30-Jan-2019 |
| Current status date | 30-Jan-2019 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TOFACITINIB (TOFACITINIB CITRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02538261 | APO-TOFACITINIB | APOTEX INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Approved |
| 02538253 | APO-TOFACITINIB | APOTEX INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Approved |
| 02530007 | AURO-TOFACITINIB | AURO PHARMA INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02530015 | AURO-TOFACITINIB | AURO PHARMA INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Marketed |
| 02570181 | DEVATIS TOFACITINIB | DEVATIS CANADA INC. | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Approved |
| 02570173 | DEVATIS TOFACITINIB | DEVATIS CANADA INC. | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Approved |
| 02522896 | JAMP TOFACITINIB | JAMP PHARMA CORPORATION | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02522799 | PMS-TOFACITINIB | PHARMASCIENCE INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02551691 | SANDOZ TOFACITINIB | SANDOZ CANADA INCORPORATED | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02551705 | SANDOZ TOFACITINIB | SANDOZ CANADA INCORPORATED | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Marketed |
| 02511312 | TARO-TOFACITINIB | TARO PHARMACEUTICALS INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Marketed |
| 02511304 | TARO-TOFACITINIB | TARO PHARMACEUTICALS INC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02553988 | TARO-TOFACITINIB XR | TARO PHARMACEUTICALS INC | Tablet (Extended-Release) | TOFACITINIB (TOFACITINIB CITRATE) 11 MG | Marketed |
| 02423898 | XELJANZ | PFIZER CANADA ULC | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Marketed |
| 02470608 | XELJANZ XR | PFIZER CANADA ULC | Tablet (Extended-Release) | TOFACITINIB (TOFACITINIB CITRATE) 11 MG | Marketed |
| 02544318 | TEVA-TOFACITINIB | TEVA CANADA LIMITED | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 5 MG | Cancelled Pre Market |
| 02544326 | TEVA-TOFACITINIB | TEVA CANADA LIMITED | Tablet | TOFACITINIB (TOFACITINIB CITRATE) 10 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 21299 | 2018-09-11 | Supplement to a New Drug Submission (SNDS) | TO SEEK MARKET AUTHORIZATION OF XELJANZ FOR A NEW INDICATION |