APO-ABIRATERONE FILM COATED TABLETS DIN 02491400
Health Canada record
| Active ingredient(s) | ABIRATERONE ACETATE 500 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L02BX03 ABIRATERONE |
| Original market date | 25-Jan-2021 |
| Current status date | 25-Jan-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ABIRATERONE ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02525372 | ABIRATERONE | JAMP PHARMA CORPORATION | Tablet | ABIRATERONE ACETATE 250 MG | Approved |
| 02473917 | APO-ABIRATERONE | APOTEX INC | Tablet | ABIRATERONE ACETATE 250 MG | Approved |
| 02496100 | APO-ABIRATERONE ACETATE FILM COATED TABLETS | APOTEX INC | Tablet | ABIRATERONE ACETATE 500 MG | Approved |
| 02491397 | APO-ABIRATERONE FILM COATED TABLETS | APOTEX INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02570637 | EUGIA-ABIRATERONE | EUGIA PHARMA INC. | Tablet | ABIRATERONE ACETATE 250 MG | Approved |
| 02570645 | EUGIA-ABIRATERONE | EUGIA PHARMA INC. | Tablet | ABIRATERONE ACETATE 500 MG | Approved |
| 02529629 | JAMP ABIRATERONE | JAMP PHARMA CORPORATION | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02502305 | JAMP ABIRATERONE | JAMP PHARMA CORPORATION | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02503980 | MAR-ABIRATERONE | MARCAN PHARMACEUTICALS INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02503999 | MAR-ABIRATERONE | MARCAN PHARMACEUTICALS INC | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02494132 | NAT-ABIRATERONE | NATCO PHARMA (CANADA) INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02501503 | PMS-ABIRATERONE | PHARMASCIENCE INC | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02492601 | PMS-ABIRATERONE | PHARMASCIENCE INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02540460 | PRZ-ABIRATERONE | PHARMARIS CANADA INC | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02540452 | PRZ-ABIRATERONE | PHARMARIS CANADA INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02477114 | REDDY-ABIRATERONE | DR REDDY'S LABORATORIES LTD | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02533251 | REDDY-ABIRATERONE | DR REDDY'S LABORATORIES LTD | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02569981 | RIVA-ABIRATERONE | LABORATOIRE RIVA INC. | Tablet | ABIRATERONE ACETATE 500 MG | Approved |
| 02569973 | RIVA-ABIRATERONE | LABORATOIRE RIVA INC. | Tablet | ABIRATERONE ACETATE 250 MG | Approved |
| 02486393 | SANDOZ ABIRATERONE | SANDOZ CANADA INCORPORATED | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02521652 | SANDOZ ABIRATERONE | SANDOZ CANADA INCORPORATED | Tablet | ABIRATERONE ACETATE 1000 MG | Approved |
| 02521644 | SANDOZ ABIRATERONE | SANDOZ CANADA INCORPORATED | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02371065 | ZYTIGA | JANSSEN INC | Tablet | ABIRATERONE ACETATE 250 MG | Marketed |
| 02457113 | ZYTIGA | JANSSEN INC | Tablet | ABIRATERONE ACETATE 500 MG | Marketed |
| 02525380 | ABIRATERONE | JAMP PHARMA CORPORATION | Tablet | ABIRATERONE ACETATE 500 MG | Dormant |
| 02473356 | TEVA-ABIRATERONE | TEVA CANADA LIMITED | Tablet | ABIRATERONE ACETATE 250 MG | Cancelled Pre Market |
| 02487446 | TEVA-ABIRATERONE | TEVA CANADA LIMITED | Tablet | ABIRATERONE ACETATE 500 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 24965 | 2021-01-11 | Supplement to an Abbreviated New Drug Submission (SANDS) | ADDITION OF A NEW MANUFACTURING SITE. ADDITION OF A NEW DOSAGE FORM AND STRENGTH |
International API supply for ABIRATERONE ACETATE
27 active FDA Drug Master Files.
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