SANDOZ FLUVASTATIN XL DIN 02492385
Status: Cancelled Pre Market
Holder: SANDOZ CANADA INCORPORATED
Molecule: FLUVASTATIN (FLUVASTATIN SODIUM)
Health Canada record
| Active ingredient(s) | FLUVASTATIN (FLUVASTATIN SODIUM) 80 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C10AA04 FLUVASTATIN |
| Original market date | |
| Current status date | 26-Oct-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLUVASTATIN (FLUVASTATIN SODIUM)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02299224 | TEVA-FLUVASTATIN | TEVA CANADA LIMITED | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 20 MG | Marketed |
| 02299232 | TEVA-FLUVASTATIN | TEVA CANADA LIMITED | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 40 MG | Marketed |
| 02061562 | LESCOL 20MG | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 20 MG | Cancelled Post Market |
| 02061570 | LESCOL 40MG | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 40 MG | Cancelled Post Market |
| 02250527 | LESCOL XL | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet (Extended-Release) | FLUVASTATIN (FLUVASTATIN SODIUM) 80 MG | Cancelled Post Market |
| 02400243 | SANDOZ FLUVASTATIN | SANDOZ CANADA INCORPORATED | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 40 MG | Cancelled Post Market |
| 02400235 | SANDOZ FLUVASTATIN | SANDOZ CANADA INCORPORATED | Capsule | FLUVASTATIN (FLUVASTATIN SODIUM) 20 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22689 | 2019-09-24 | New Drug Submission (NDS) | LABEL REVIEW. ADMINISTRATIVE LICENSING AGREEMENT BETWEEN TWO COMPANIES |