APO-DARIFENACIN DIN 02452510
Status: Marketed
Holder: APOTEX INC
Molecule: DARIFENACIN (DARIFENACIN HYDROBROMIDE)
Available to quote
Health Canada record
| Active ingredient(s) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04BD10 DARIFENACIN |
| Original market date | 28-Jul-2021 |
| Current status date | 28-Jul-2021 |
| 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 DARIFENACIN (DARIFENACIN HYDROBROMIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02452529 | APO-DARIFENACIN | APOTEX INC | Tablet (Extended-Release) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15 MG | Marketed |
| 02273217 | ENABLEX | SEARCHLIGHT PHARMA INC | Tablet (Extended-Release) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5 MG | Marketed |
| 02273225 | ENABLEX | SEARCHLIGHT PHARMA INC | Tablet (Extended-Release) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15 MG | Marketed |
| 02491869 | JAMP DARIFENACIN | JAMP PHARMA CORPORATION | Tablet (Extended-Release) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5 MG | Marketed |
| 02491877 | JAMP DARIFENACIN | JAMP PHARMA CORPORATION | Tablet (Extended-Release) | DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18398 | 2016-08-23 | Abbreviated New Drug Submission (ANDS) |