APO-BILASTINE ORODISPERSIBLE TABLETS DIN 02549875
Health Canada record
| Active ingredient(s) | BILASTINE 10 MG |
|---|---|
| Dosage form | Tablet (Orally-Disintegrating) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R06AX OTHER ANTIHISTAMINES FOR SYSTEMIC USE |
| Original market date | |
| Current status date | 30-Aug-2024 |
| 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 BILASTINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02570521 | APO- BILASTINE | APOTEX INC | Tablet | BILASTINE 20 MG | Approved |
| 02549867 | APO-BILASTINE ORAL SOLUTION | APOTEX INC | Solution | BILASTINE 2.5 MG | Approved |
| 02549883 | APO-BILASTINE TABLETS | APOTEX INC | Tablet | BILASTINE 20 MG | Marketed |
| 02541556 | AURO-BILASTINE | AURO PHARMA INC | Tablet | BILASTINE 20 MG | Marketed |
| 02454130 | BLEXTEN | ARALEZ PHARMACEUTICALS CANADA INC | Tablet | BILASTINE 20 MG | Marketed |
| 02519038 | BLEXTEN | ARALEZ PHARMACEUTICALS CANADA INC | Tablet (Orally-Disintegrating) | BILASTINE 10 MG | Marketed |
| 02519011 | BLEXTEN | ARALEZ PHARMACEUTICALS CANADA INC | Solution | BILASTINE 2.5 MG | Marketed |
| 02561514 | BLEXTEN | ARALEZ PHARMACEUTICALS CANADA INC | Solution | BILASTINE 6 MG | Approved |
| 02544369 | GLN-BILASTINE | GLENMARK PHARMACEUTICALS CANADA INC. | Tablet | BILASTINE 20 MG | Marketed |
| 02546795 | JAMP BILASTINE | JAMP PHARMA CORPORATION | Tablet | BILASTINE 20 MG | Marketed |
| 02448262 | JAMP BILASTINE ORAL SOLUTION | JAMP PHARMA CORPORATION | Solution | BILASTINE 2.5 MG | Marketed |
| 02548410 | M-BILASTINE | MANTRA PHARMA INC | Tablet | BILASTINE 20 MG | Marketed |
| 02547279 | MAR-BILASTINE | MARCAN PHARMACEUTICALS INC | Tablet | BILASTINE 20 MG | Marketed |
| 02568772 | MINT-BILASTINE | MINT PHARMACEUTICALS INC | Tablet | BILASTINE 20 MG | Approved |
| 02551934 | NRA-BILASTINE | NORA PHARMA INC | Tablet | BILASTINE 20 MG | Marketed |
| 02561565 | PMS-BILASTINE | PHARMASCIENCE INC | Tablet | BILASTINE 20 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33914 | 2024-08-30 | New Drug Submission (NDS) | Administrative: Licensing Agreement between two manufacturers |
International API supply for BILASTINE
13 active FDA Drug Master Files.
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