APTIOM DIN 02426870
Status: Cancelled Post Market
Holder: SUMITOMO PHARMA CANADA, INC.
Molecule: ESLICARBAZEPINE ACETATE
Available to quote
Health Canada record
| Active ingredient(s) | ESLICARBAZEPINE ACETATE 400 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AF04 ESLICARBAZEPINE |
| Original market date | 07-Aug-2014 |
| Current status date | 30-Jun-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sumitomo Pharma Canada, Inc. — licence 101940, currently licensed, last inspection rating C (2023-10-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ESLICARBAZEPINE ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02537966 | APO-ESLICARBAZEPINE | APOTEX INC | Tablet | ESLICARBAZEPINE ACETATE 600 MG | Marketed |
| 02537958 | APO-ESLICARBAZEPINE | APOTEX INC | Tablet | ESLICARBAZEPINE ACETATE 400 MG | Marketed |
| 02537974 | APO-ESLICARBAZEPINE | APOTEX INC | Tablet | ESLICARBAZEPINE ACETATE 800 MG | Marketed |
| 02537931 | APO-ESLICARBAZEPINE | APOTEX INC | Tablet | ESLICARBAZEPINE ACETATE 200 MG | Marketed |
| 02527456 | AURO-ESLICARBAZEPINE | AURO PHARMA INC | Tablet | ESLICARBAZEPINE ACETATE 600 MG | Marketed |
| 02527421 | AURO-ESLICARBAZEPINE | AURO PHARMA INC | Tablet | ESLICARBAZEPINE ACETATE 200 MG | Marketed |
| 02527448 | AURO-ESLICARBAZEPINE | AURO PHARMA INC | Tablet | ESLICARBAZEPINE ACETATE 400 MG | Marketed |
| 02527464 | AURO-ESLICARBAZEPINE | AURO PHARMA INC | Tablet | ESLICARBAZEPINE ACETATE 800 MG | Marketed |
| 02426862 | APTIOM | SUMITOMO PHARMA CANADA, INC. | Tablet | ESLICARBAZEPINE ACETATE 200 MG | Cancelled Post Market |
| 02426897 | APTIOM | SUMITOMO PHARMA CANADA, INC. | Tablet | ESLICARBAZEPINE ACETATE 800 MG | Cancelled Post Market |
| 02426889 | APTIOM | SUMITOMO PHARMA CANADA, INC. | Tablet | ESLICARBAZEPINE ACETATE 600 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32597 | 2024-01-25 | New Drug Submission (NDS) | Administrative: Manufacturer Name Change |
| 15782 | 2014-07-08 | New Drug Submission (NDS) |
International API supply for ESLICARBAZEPINE ACETATE
17 active FDA Drug Master Files.
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