TEVA-TEMOZOLOMIDE DIN 02395274
Health Canada record
| Active ingredient(s) | TEMOZOLOMIDE 20 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01AX03 TEMOZOLOMIDE |
| Original market date | 07-Nov-2012 |
| Current status date | 19-Oct-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing TEMOZOLOMIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02389819 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 20 MG | Marketed |
| 02389851 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 250 MG | Marketed |
| 02438119 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 5 MG | Marketed |
| 02389835 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 140 MG | Marketed |
| 02389827 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 100 MG | Marketed |
| 02413035 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 5 MG | Approved |
| 02413132 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 250 MG | Approved |
| 02413124 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 180 MG | Approved |
| 02413116 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 140 MG | Approved |
| 02413094 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 100 MG | Approved |
| 02413043 | APO-TEMOZOLOMIDE | APOTEX INC | Capsule | TEMOZOLOMIDE 20 MG | Approved |
| 02516845 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 250 MG | Marketed |
| 02516799 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 5 MG | Marketed |
| 02516802 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 20 MG | Marketed |
| 02516810 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 100 MG | Marketed |
| 02516829 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 140 MG | Marketed |
| 02516837 | JAMP TEMOZOLOMIDE | JAMP PHARMA CORPORATION | Capsule | TEMOZOLOMIDE 180 MG | Approved |
| 02569345 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 250 MG | Approved |
| 02569299 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 5 MG | Approved |
| 02569302 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 20 MG | Approved |
| 02569310 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 100 MG | Approved |
| 02569329 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 140 MG | Approved |
| 02569337 | MAR-TEMOZOLOMIDE | MARCAN PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 180 MG | Approved |
| 02443554 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 250 MG | Marketed |
| 02443481 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 20 MG | Marketed |
| 02443473 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 5 MG | Marketed |
| 02443511 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 100 MG | Marketed |
| 02443538 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 140 MG | Marketed |
| 02443546 | TARO-TEMOZOLOMIDE | TARO PHARMACEUTICALS INC | Capsule | TEMOZOLOMIDE 180 MG | Approved |
| 02241096 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 250 MG | Marketed |
| 02312794 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 140 MG | Marketed |
| 02241095 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 100 MG | Marketed |
| 02241094 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 20 MG | Marketed |
| 02241093 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 5 MG | Marketed |
| 02441160 | TEVA-TEMOZOLOMIDE | TEVA CANADA LIMITED | Capsule | TEMOZOLOMIDE 5 MG | Marketed |
| 02395282 | TEVA-TEMOZOLOMIDE | TEVA CANADA LIMITED | Capsule | TEMOZOLOMIDE 100 MG | Marketed |
| 02395290 | TEVA-TEMOZOLOMIDE | TEVA CANADA LIMITED | Capsule | TEMOZOLOMIDE 140 MG | Marketed |
| 02395312 | TEVA-TEMOZOLOMIDE | TEVA CANADA LIMITED | Capsule | TEMOZOLOMIDE 250 MG | Marketed |
| 02389843 | ACH-TEMOZOLOMIDE | ACCORD HEALTHCARE INC | Capsule | TEMOZOLOMIDE 180 MG | Cancelled Post Market |
| 02395304 | ACT TEMOZOLOMIDE | TEVA CANADA LIMITED | Capsule | TEMOZOLOMIDE 180 MG | Cancelled Pre Market |
| 02312816 | TEMODAL | MERCK CANADA INC | Capsule | TEMOZOLOMIDE 180 MG | Cancelled Post Market |
| 02321262 | TEMODAL | MERCK CANADA INC | Powder For Solution | TEMOZOLOMIDE 100 MG | Cancelled Post Market |
| 02455757 | TEMOZOLOMIDE CAPSULES | MDA INC. | Capsule | TEMOZOLOMIDE 20 MG | Cancelled Pre Market |
| 02455749 | TEMOZOLOMIDE CAPSULES | MDA INC. | Capsule | TEMOZOLOMIDE 5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 26872 | 2021-10-19 | Supplement to an Abbreviated New Drug Submission (SANDS) | Administrative: Product Name Change Administrative: Labelling Update (to Match Licensor) / Updates to Product Monograph New Package Insert |
| 24683 | 2020-11-26 | Abbreviated New Drug Submission (ANDS) | MERGER - BUYOUT |
| 16332 | 2014-11-20 | Abbreviated New Drug Submission (ANDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 13796 | 2012-11-01 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for TEMOZOLOMIDE
7 valid EDQM Certificates of Suitability from 7 holders. 15 active FDA Drug Master Files.
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