Approval · Notice of Compliance 5774 · 2004
SEROQUEL: Notice of Compliance 5774
Issued November 5, 2004
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
- 5774
- Date
- November 5, 2004
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: monotherapy for the acute management of manic episodes associated with bipolar disorder
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SEROQUEL | Not yet assigned | — |
Medicinal ingredients
- QUETIAPINE FUMARATE 25 MG per TAB
- QUETIAPINE FUMARATE 100 MG per TAB
- QUETIAPINE FUMARATE 150 MG per TAB
- QUETIAPINE FUMARATE 200 MG per TAB
- QUETIAPINE FUMARATE 300 MG per TAB