Approval · Notice of Compliance 15836 · 2014
APO-DUTASTERIDE: Notice of Compliance 15836
Issued July 18, 2014
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
- 15836
- Date
- July 18, 2014
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Addition of container closure system (blister pack)
- Therapeutic class
- Type I and II 5 alpha reductase inhibitor
- Canadian reference product
- AVODART (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-DUTASTERIDE | Not yet assigned | — |
Medicinal ingredients
- DUTASTERIDE 0.5 MG per CAP