AURO-FLECAINIDE DIN 02459957
Health Canada record
| Active ingredient(s) | FLECAINIDE ACETATE 50 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C01BC04 FLECAINIDE |
| Original market date | 27-Feb-2017 |
| Current status date | 27-Feb-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Auro Pharma Inc — licence 101305, currently licensed, last inspection rating C (2023-09-27).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FLECAINIDE ACETATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02516071 | AG-FLECAINIDE | ANGITA PHARMA INC. | Tablet | FLECAINIDE ACETATE 100 MG | Marketed |
| 02516063 | AG-FLECAINIDE | ANGITA PHARMA INC. | Tablet | FLECAINIDE ACETATE 50 MG | Marketed |
| 02275546 | APO-FLECAINIDE | APOTEX INC | Tablet | FLECAINIDE ACETATE 100 MG | Marketed |
| 02275538 | APO-FLECAINIDE | APOTEX INC | Tablet | FLECAINIDE ACETATE 50 MG | Marketed |
| 02459965 | AURO-FLECAINIDE | AURO PHARMA INC | Tablet | FLECAINIDE ACETATE 100 MG | Marketed |
| 02534819 | FLECAINIDE | SANIS HEALTH INC | Tablet | FLECAINIDE ACETATE 100 MG | Marketed |
| 02534800 | FLECAINIDE | SANIS HEALTH INC | Tablet | FLECAINIDE ACETATE 50 MG | Marketed |
| 02493705 | JAMP FLECAINIDE | JAMP PHARMA CORPORATION | Tablet | FLECAINIDE ACETATE 50 MG | Marketed |
| 02493713 | JAMP FLECAINIDE | JAMP PHARMA CORPORATION | Tablet | FLECAINIDE ACETATE 100 MG | Marketed |
| 02476185 | MAR-FLECAINIDE | MARCAN PHARMACEUTICALS INC | Tablet | FLECAINIDE ACETATE 100 MG | Dormant |
| 02476177 | MAR-FLECAINIDE | MARCAN PHARMACEUTICALS INC | Tablet | FLECAINIDE ACETATE 50 MG | Dormant |
| 02530066 | NRA-FLECAINIDE | NORA PHARMA INC | Tablet | FLECAINIDE ACETATE 50 MG | Cancelled Post Market |
| 02530074 | NRA-FLECAINIDE | NORA PHARMA INC | Tablet | FLECAINIDE ACETATE 100 MG | Cancelled Post Market |
| 01966197 | TAMBOCOR | BAUSCH HEALTH, CANADA INC. | Tablet | FLECAINIDE ACETATE 50 MG | Dormant |
| 01966200 | TAMBOCOR | BAUSCH HEALTH, CANADA INC. | Tablet | FLECAINIDE ACETATE 100 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18794 | 2016-12-20 | Abbreviated New Drug Submission (ANDS) |
International API supply for FLECAINIDE ACETATE
8 valid EDQM Certificates of Suitability from 8 holders. 10 active FDA Drug Master Files.
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