Approval · Notice of Compliance 9677 · 2008
DILANTIN: Notice of Compliance 9677
Issued July 11, 2008
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
- 9677
- Date
- July 11, 2008
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Change in manufacturing process and site for drug substance and product with bioequivalence study
- Therapeutic class
- Anticonvulsant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DILANTIN | Not yet assigned | — |
Medicinal ingredients
- PHENYTOIN SODIUM 100 MG per CAP