Approval · Notice of Compliance 6378 · 2005
CLARUS: Notice of Compliance 6378
Issued March 31, 2005
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
- 6378
- Date
- March 31, 2005
- Company
- Prempharm Inc.Etobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Other
- 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 TAB