XELODA DIN 02238453
Health Canada record
| Active ingredient(s) | CAPECITABINE 150 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01BC06 CAPECITABINE |
| Original market date | 10-Sep-1998 |
| Current status date | 07-Dec-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cheplapharm Arzneimittel GmbH — licence , not currently licensed, last inspection rating C (2024-10-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CAPECITABINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02426757 | ACH-CAPECITABINE | ACCORD HEALTHCARE INC | Tablet | CAPECITABINE 150 MG | Marketed |
| 02426765 | ACH-CAPECITABINE | ACCORD HEALTHCARE INC | Tablet | CAPECITABINE 500 MG | Marketed |
| 02434504 | APO-CAPECITABINE | APOTEX INC | Tablet | CAPECITABINE 150 MG | Approved |
| 02434512 | APO-CAPECITABINE | APOTEX INC | Tablet | CAPECITABINE 500 MG | Approved |
| 02514982 | CAPECITABINE | SANIS HEALTH INC | Tablet | CAPECITABINE 150 MG | Marketed |
| 02519879 | CAPECITABINE | JAMP PHARMA CORPORATION | Tablet | CAPECITABINE 150 MG | Marketed |
| 02528126 | CAPECITABINE | SIVEM PHARMACEUTICALS ULC | Tablet | CAPECITABINE 150 MG | Approved |
| 02519887 | CAPECITABINE | JAMP PHARMA CORPORATION | Tablet | CAPECITABINE 500 MG | Marketed |
| 02528150 | CAPECITABINE | SIVEM PHARMACEUTICALS ULC | Tablet | CAPECITABINE 500 MG | Approved |
| 02514990 | CAPECITABINE | SANIS HEALTH INC | Tablet | CAPECITABINE 500 MG | Marketed |
| 02508028 | MINT-CAPECITABINE | MINT PHARMACEUTICALS INC | Tablet | CAPECITABINE 500 MG | Marketed |
| 02508001 | MINT-CAPECITABINE | MINT PHARMACEUTICALS INC | Tablet | CAPECITABINE 150 MG | Approved |
| 02421925 | SANDOZ CAPECITABINE | SANDOZ CANADA INCORPORATED | Tablet | CAPECITABINE 500 MG | Marketed |
| 02421917 | SANDOZ CAPECITABINE | SANDOZ CANADA INCORPORATED | Tablet | CAPECITABINE 150 MG | Marketed |
| 02457490 | TARO-CAPECITABINE | TARO PHARMACEUTICALS INC | Tablet | CAPECITABINE 150 MG | Marketed |
| 02457504 | TARO-CAPECITABINE | TARO PHARMACEUTICALS INC | Tablet | CAPECITABINE 500 MG | Marketed |
| 02400030 | TEVA-CAPECITABINE | TEVA CANADA LIMITED | Tablet | CAPECITABINE 500 MG | Cancelled Post Market |
| 02400022 | TEVA-CAPECITABINE | TEVA CANADA LIMITED | Tablet | CAPECITABINE 150 MG | Cancelled Post Market |
| 02238454 | XELODA | CHEPLAPHARM ARZNEIMITTEL GMBH | Tablet | CAPECITABINE 500 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 29099 | 2022-09-23 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 2752 | 1998-08-31 | New Drug Submission (NDS) |
International API supply for CAPECITABINE
14 valid EDQM Certificates of Suitability from 14 holders. 18 active FDA Drug Master Files.
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