Approval · Notice of Compliance 16986 · 2015
OTEZLA: Notice of Compliance 16986
Issued June 10, 2015
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
- 16986
- Date
- June 10, 2015
- Company
- Celgene IncSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Other
- Therapeutic class
- Phosphodiesterase 4 (pde4) inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OTEZLA | Not yet assigned | — |
| OTEZLA (27-COUNT STARTER PACK) | Not yet assigned | — |
Medicinal ingredients
- APREMILAST 30 MG per TAB
- APREMILAST 10 MG per TAB
- APREMILAST 20 MG per TAB