Approval · Notice of Compliance 30135 · 2023
ZOLOFT: Notice of Compliance 30135
Issued February 16, 2023
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
- 30135
- Date
- February 16, 2023
- Company
- Upjohn Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the bottle labels to comply with the Plain Language Labelling (PLL) requirements.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZOLOFT | Not yet assigned | — |
Medicinal ingredients
- SERTRALINE HYDROCHLORIDE 25 MG per CAP
- SERTRALINE HYDROCHLORIDE 50 MG per CAP
- SERTRALINE HYDROCHLORIDE 100 MG per CAP