Drug · DIN 00582352
ACCUTANE
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since September 5, 2025; first marketed December 31, 1983.
- Drug Identification Number (DIN)
- 00582352
- Company (DIN owner)
- Cheplapharm Schweiz GmbhBinningen, Switzerland
- Schedule
- Prescription
- Dosage form
- Capsule
- Route
- Oral
- Therapeutic class (ATC)
- Isotretinoin D10BA01
- Class
- Human
- Record last updated
- July 31, 2026
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| ISOTRETINOIN | 40 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- September 5, 2025: NOC 35975New Drug Submission (NDS) · Administrative: Change in manufacturer and product name
- April 2, 2001: NOC 2343Supplement to a New Drug Submission (SNDS) · Product name change from accutane
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “accutane”. A notice may cover another product or only some lots: read it to see what it covers.
- Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - For the PublicFebruary 16, 2010 · Drugs
- Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - For Health ProfessionalsFebruary 16, 2010 · Drugs
Other DINs named ACCUTANE
- DIN 00582344 · Marketed