Approval · Notice of Compliance 10330 · 2009
CLARUS: Notice of Compliance 10330
Issued July 2, 2009
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
- 10330
- Date
- July 2, 2009
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Nodular / Inflammatory and Conglobate Acne Therapy
- Canadian reference product
- ACCUTANE ROCHE (Hoffmann-La Roche Limited)
Products in this notice
Medicinal ingredients
- ISOTRETINOIN 10 MG per CAP
- ISOTRETINOIN 40 MG per CAP