Approval · Notice of Compliance 23654 · 2020
FOQUEST: Notice of Compliance 23654
Issued May 22, 2020
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
- 23654
- Date
- May 22, 2020
- Company
- Purdue PharmaToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Update existing design and layout of the approved labels to accommodate a change in bottle size and shape. Package Insert updated to be in line with PLL.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOQUEST | Not yet assigned | — |
Medicinal ingredients
- METHYLPHENIDATE HYDROCHLORIDE 25 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 35 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 45 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 55 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 70 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 85 MG per CAP
- METHYLPHENIDATE HYDROCHLORIDE 100 MG per CAP