TEVA-DEXTROAMPHETAMINE SR DIN 02448327
Health Canada record
| Active ingredient(s) | DEXTROAMPHETAMINE SULFATE 15 MG |
|---|---|
| Dosage form | Capsule (Sustained-Release) |
| Route | Oral |
| Schedule | CONTROLLED DRUGS (CDSA I) |
| Class | Human |
| ATC | N06BA02 DEXAMFETAMINE |
| Original market date | 06-Oct-2017 |
| Current status date | 13-Aug-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Teva Canada Limited — licence 101810, currently licensed, last inspection rating C (2025-03-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DEXTROAMPHETAMINE SULFATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02481464 | APO-DEXTROAMPHETAMINE SR | APOTEX INC | Capsule (Sustained-Release) | DEXTROAMPHETAMINE SULFATE 10 MG | Approved |
| 02481472 | APO-DEXTROAMPHETAMINE SR | APOTEX INC | Capsule (Sustained-Release) | DEXTROAMPHETAMINE SULFATE 15 MG | Approved |
| 01924516 | DEXEDRINE | KNIGHT THERAPEUTICS INC. | Tablet | DEXTROAMPHETAMINE SULFATE 5 MG | Marketed |
| 01924559 | DEXEDRINE SPANSULE | KNIGHT THERAPEUTICS INC. | Capsule (Sustained-Release) | DEXTROAMPHETAMINE SULFATE 10 MG | Marketed |
| 01924567 | DEXEDRINE SPANSULE | KNIGHT THERAPEUTICS INC. | Capsule (Sustained-Release) | DEXTROAMPHETAMINE SULFATE 15 MG | Marketed |
| 02443236 | DEXTROAMPHETAMINE | AA PHARMA INC | Tablet | DEXTROAMPHETAMINE SULFATE 5 MG | Marketed |
| 02566605 | PMS-DEXTROAMPHETAMINE | PHARMASCIENCE INC | Tablet | DEXTROAMPHETAMINE SULFATE 5 MG | Approved |
| 02448319 | TEVA-DEXTROAMPHETAMINE SR | TEVA CANADA LIMITED | Capsule (Sustained-Release) | DEXTROAMPHETAMINE SULFATE 10 MG | Marketed |
| 02447673 | PMS-DEXTROAMPHETAMINE | PHARMASCIENCE INC | Tablet | DEXTROAMPHETAMINE SULFATE 5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 33058 | 2024-04-12 | Supplement to a New Drug Submission (SNDS) | Administrative: Product Name Change. Update to the Product Monograph. Update to labels |
| 23006 | 2019-12-11 | New Drug Submission (NDS) | MERGER - BUYOUT |
| 17424 | 2015-10-27 | New Drug Submission (NDS) |
International API supply for DEXTROAMPHETAMINE SULFATE
8 active FDA Drug Master Files.
Request a quote for TEVA-DEXTROAMPHETAMINE SR