Approval · Notice of Compliance 36686 · 2026
CLARUS: Notice of Compliance 36686
Issued January 6, 2026
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
- 36686
- Date
- January 6, 2026
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph (to align with CRP approved PM) . Update to package insert. Update to package labels
- Canadian reference product
- ACCUTANE ROCHE (Hoffmann-La Roche Limited)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CLARUS | Not yet assigned | — |
Medicinal ingredients
- ISOTRETINOIN 10 MG per CAP
- ISOTRETINOIN 40 MG per CAP