MINT-MEXILETINE DIN 02536854
Status: Marketed
Holder: MINT PHARMACEUTICALS INC
Molecule: MEXILETINE HYDROCHLORIDE
Available to quote
Health Canada record
| Active ingredient(s) | MEXILETINE HYDROCHLORIDE 200 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C01BB02 MEXILETINE |
| Original market date | 18-Jan-2024 |
| Current status date | 18-Jan-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mint Pharmaceuticals Inc — licence 101613, currently licensed, last inspection rating C (2023-01-16).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MEXILETINE HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02536846 | MINT-MEXILETINE | MINT PHARMACEUTICALS INC | Capsule | MEXILETINE HYDROCHLORIDE 100 MG | Marketed |
| 02230359 | TEVA-MEXILETINE | TEVA CANADA LIMITED | Capsule | MEXILETINE HYDROCHLORIDE 100 MG | Marketed |
| 02230360 | TEVA-MEXILETINE | TEVA CANADA LIMITED | Capsule | MEXILETINE HYDROCHLORIDE 200 MG | Marketed |
| 02231690 | ALTI-MEXILETINE | ALTIMED PHARMA INC. | Capsule | MEXILETINE HYDROCHLORIDE 100 MG | Cancelled Post Market |
| 02231692 | ALTI-MEXILETINE | ALTIMED PHARMA INC. | Capsule | MEXILETINE HYDROCHLORIDE 200 MG | Cancelled Post Market |
| 00599956 | MEXITIL CAP 100MG | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | MEXILETINE HYDROCHLORIDE 100 MG | Cancelled Post Market |
| 00599964 | MEXITIL CAP 200MG | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | MEXILETINE HYDROCHLORIDE 200 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 30433 | 2023-03-31 | Abbreviated New Drug Submission (ANDS) |
International API supply for MEXILETINE HYDROCHLORIDE
4 valid EDQM Certificates of Suitability from 4 holders. 7 active FDA Drug Master Files.
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