ACH-FESOTERODINE DIN 02536005
Health Canada record
| Active ingredient(s) | FESOTERODINE FUMARATE 8 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04BD11 FESOTERODINE |
| Original market date | 21-May-2026 |
| Current status date | 21-May-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Accord Healthcare Inc. — licence 101566, currently licensed, last inspection rating C (2024-11-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FESOTERODINE FUMARATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02535998 | ACH-FESOTERODINE | ACCORD HEALTHCARE INC | Tablet (Extended-Release) | FESOTERODINE FUMARATE 4 MG | Marketed |
| 02493462 | APO-FESOTERODINE | APOTEX INC | Tablet (Extended-Release) | FESOTERODINE FUMARATE 4 MG | Approved |
| 02493470 | APO-FESOTERODINE | APOTEX INC | Tablet (Extended-Release) | FESOTERODINE FUMARATE 8 MG | Approved |
| 02521768 | SANDOZ FESOTERODINE FUMARATE | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | FESOTERODINE FUMARATE 4 MG | Marketed |
| 02521776 | SANDOZ FESOTERODINE FUMARATE | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | FESOTERODINE FUMARATE 8 MG | Marketed |
| 02380021 | TOVIAZ | PFIZER CANADA ULC | Tablet (Extended-Release) | FESOTERODINE FUMARATE 4 MG | Marketed |
| 02380048 | TOVIAZ | PFIZER CANADA ULC | Tablet (Extended-Release) | FESOTERODINE FUMARATE 8 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30285 | 2023-03-09 | Abbreviated New Drug Submission (ANDS) |
International API supply for FESOTERODINE FUMARATE
13 active FDA Drug Master Files.
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