APO-MODAFINIL DIN 02285398
Health Canada record
| Active ingredient(s) | MODAFINIL 100 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N06BA07 MODAFINIL |
| Original market date | 01-May-2008 |
| Current status date | 19-Sep-2014 |
| 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 MODAFINIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02239665 | ALERTEC | NEURAXPHARM PHARMACEUTICALS, S.L. | Tablet | MODAFINIL 100 MG | Marketed |
| 02430487 | AURO-MODAFINIL | AURO PHARMA INC | Tablet | MODAFINIL 100 MG | Marketed |
| 02432013 | IPG-MODAFINIL | MARCAN PHARMACEUTICALS INC | Tablet | MODAFINIL 100 MG | Approved |
| 02503727 | JAMP MODAFINIL | JAMP PHARMA CORPORATION | Tablet | MODAFINIL 100 MG | Marketed |
| 02432560 | MAR-MODAFINIL | MARCAN PHARMACEUTICALS INC | Tablet | MODAFINIL 100 MG | Marketed |
| 02530244 | MODAFINIL | SANIS HEALTH INC | Tablet | MODAFINIL 100 MG | Marketed |
| 02479303 | MODAFINIL TABLETS | STRIDES PHARMA CANADA INC | Tablet | MODAFINIL 100 MG | Approved |
| 02420260 | TEVA-MODAFINIL | TEVA CANADA LIMITED | Tablet | MODAFINIL 100 MG | Marketed |
| 02442078 | BIO-MODAFINIL | BIOMED PHARMA | Tablet | MODAFINIL 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 16096 | 2014-09-16 | Abbreviated New Drug Submission (ANDS) | TRANSFER OF DDRUG IDENTIFICATION NUMBER |
| 12998 | 2012-02-02 | Abbreviated New Drug Submission (ANDS) | Manufacturer and product name change |
| 9531 | 2008-05-01 | Abbreviated New Drug Submission (ANDS) |
International API supply for MODAFINIL
9 valid EDQM Certificates of Suitability from 9 holders. 20 active FDA Drug Master Files.
Request a quote for APO-MODAFINIL