APO-CLADRIBINE DIN 02553295
Health Canada record
| Active ingredient(s) | CLADRIBINE 10 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AA40* CLADRIBINE |
| Original market date | 22-Dec-2025 |
| Current status date | 22-Dec-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-09-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CLADRIBINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02566443 | AURO-CLADRIBINE | AURO PHARMA INC | Tablet | CLADRIBINE 10 MG | Marketed |
| 02319918 | CLADRIBINE INJECTION | FRESENIUS KABI CANADA LTD | Solution | CLADRIBINE 1 MG | Marketed |
| 02494574 | CLADRIBINE INJECTION | GENERIC MEDICAL PARTNERS INC | Solution | CLADRIBINE 1 MG | Marketed |
| 02470179 | MAVENCLAD | EMD SERONO, A DIVISION OF EMD INC., CANADA | Tablet | CLADRIBINE 10 MG | Marketed |
| 02022117 | LEUSTATIN 1MG/ML | JANSSEN INC | Solution | CLADRIBINE 1 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36405 | 2025-11-20 | Abbreviated New Drug Submission (ANDS) |
International API supply for CLADRIBINE
5 valid EDQM Certificates of Suitability from 5 holders. 10 active FDA Drug Master Files.
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