CORZYNA DIN 02558955
Health Canada record
| Active ingredient(s) | RANOLAZINE 750 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C01EB18 RANOLAZINE |
| Original market date | |
| Current status date | 30-Jun-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
KYE Pharmaceuticals Inc. — licence 3-002615, currently licensed, last inspection rating C (2025-09-08).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RANOLAZINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02510219 | CORZYNA | KYE PHARMACEUTICALS INC. | Tablet (Extended-Release) | RANOLAZINE 500 MG | Marketed |
| 02510227 | CORZYNA | KYE PHARMACEUTICALS INC. | Tablet (Extended-Release) | RANOLAZINE 1000 MG | Marketed |
| 02558947 | CORZYNA | KYE PHARMACEUTICALS INC. | Tablet (Extended-Release) | RANOLAZINE 375 MG | Approved |
| 02562448 | MAR-RANOLAZINE XR | MARCAN PHARMACEUTICALS INC | Tablet (Extended-Release) | RANOLAZINE 500 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35602 | 2025-06-30 | Supplement to a New Drug Submission (SNDS) | Product Monograph reformatted to the Master Template. Addition of new strength: 375 and 750 mg. Addition of a manufacturing site and/or manufacturer involving production of the starting material. Addition of a drug product manufacturing site and/or manufacturer involving production. New package insert. New package labels |
International API supply for RANOLAZINE
24 active FDA Drug Master Files.
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