Approval · Notice of Compliance 8570 · 2007
ADDERALL XR: Notice of Compliance 8570
Issued February 5, 2007
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 8570
- Date
- February 5, 2007
- Company
- Shire Biochem Inc.Saint Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications for adult and for adolescent patient populations and other revisions to the product monograph
- Therapeutic class
- Cns stimulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADDERALL XR | Not yet assigned | — |
Medicinal ingredients
- AMPHETAMINE SULFATE 1.25 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 MG per CAP
- DEXTROAMPHETAMINE SULFATE 1.25 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 1.25 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 MG per CAP
- AMPHETAMINE SULFATE 2.5 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 2.5 MG per CAP
- DEXTROAMPHETAMINE SULFATE 2.5 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 MG per CAP
- AMPHETAMINE SULFATE 3.75 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 3.75 MG per CAP
- DEXTROAMPHETAMINE SULFATE 3.75 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 5 MG per CAP
- AMPHETAMINE SULFATE 5 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 5 MG per CAP
- DEXTROAMPHETAMINE SULFATE 5 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 MG per CAP
- AMPHETAMINE SULFATE 6.25 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 6.25 MG per CAP
- DEXTROAMPHETAMINE SULFATE 6.25 MG per CAP
- AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 MG per CAP
- AMPHETAMINE SULFATE 7.5 MG per CAP
- DEXTROAMPHETAMINE SACCHARATE 7.5 MG per CAP
- DEXTROAMPHETAMINE SULFATE 7.5 MG per CAP