BICALUTAMIDE DIN 02382423
Health Canada record
| Active ingredient(s) | BICALUTAMIDE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L02BB03 BICALUTAMIDE |
| Original market date | 10-Jun-2012 |
| Current status date | 22-Jan-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sivem Pharmaceuticals ULC — licence 101965, currently licensed, last inspection rating C (2025-02-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing BICALUTAMIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02325985 | ACH-BICALUTAMIDE | ACCORD HEALTHCARE INC | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02519178 | BICALUTAMIDE | SANIS HEALTH INC | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02357216 | JAMP BICALUTAMIDE | JAMP PHARMA CORPORATION | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02407531 | MED-BICALUTAMIDE | GENERIC MEDICAL PARTNERS INC | Tablet | BICALUTAMIDE 50 MG | Approved |
| 02565919 | NRA-BICALUTAMIDE | NORA PHARMA INC | Tablet | BICALUTAMIDE 50 MG | Approved |
| 02275589 | PMS-BICALUTAMIDE | PHARMASCIENCE INC | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02311038 | PRO-BICALUTAMIDE | PRO DOC LIMITEE | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02270226 | TEVA-BICALUTAMIDE | TEVA CANADA LIMITED | Tablet | BICALUTAMIDE 50 MG | Marketed |
| 02400731 | ACCEL-BICALUTAMIDE TABLETS USP | ACCEL PHARMA INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Pre Market |
| 02274337 | ACT BICALUTAMIDE | ACTAVIS PHARMA COMPANY | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02374412 | AG-BICALUTAMIDE | ANGITA PHARMA INC. | Tablet | BICALUTAMIDE 50 MG | Cancelled Pre Market |
| 02296063 | APO-BICALUTAMIDE | APOTEX INC | Tablet | BICALUTAMIDE 50 MG | Dormant |
| 02360993 | AVA-BICALUTAMIDE | AVANSTRA INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02325233 | BICALUTAMIDE | SORRES PHARMA INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02360098 | BICALUTAMIDE TABLETS | FRESENIUS KABI CANADA LTD | Tablet | BICALUTAMIDE 50 MG | Cancelled Pre Market |
| 02184478 | CASODEX | ASTRAZENECA CANADA INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02281139 | DOM-BICALUTAMIDE | DOMINION PHARMACAL | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02302403 | MYLAN-BICALUTAMIDE | MYLAN PHARMACEUTICALS ULC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02358557 | NTP-BICALUTAMIDE | TEVA CANADA LIMITED | Tablet | BICALUTAMIDE 50 MG | Cancelled Pre Market |
| 02336545 | NU-BICALUTAMIDE | NU-PHARM INC | Tablet | BICALUTAMIDE 50 MG | Cancelled (Unreturned Annual) |
| 02281163 | PHL-BICALUTAMIDE | PHARMEL INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02371324 | RAN-BICALUTAMIDE | RANBAXY PHARMACEUTICALS CANADA INC. | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02277700 | RATIO-BICALUTAMIDE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02276089 | SANDOZ BICALUTAMIDE | SANDOZ CANADA INCORPORATED | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
| 02428709 | VAN-BICALUTAMIDE | VANC PHARMACEUTICALS INC | Tablet | BICALUTAMIDE 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 16504 | 2015-01-08 | Abbreviated New Drug Submission (ANDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES |
| 13230 | 2012-04-23 | Abbreviated New Drug Submission (ANDS) | New manufacturer and product name |
International API supply for BICALUTAMIDE
6 valid EDQM Certificates of Suitability from 6 holders. 9 active FDA Drug Master Files.
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