Approval · Notice of Compliance 22366 · 2019
APO-GABAPENTIN: Notice of Compliance 22366
Issued July 5, 2019
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
- 22366
- Date
- July 5, 2019
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Licensing agreement between two companies
- Canadian reference product
- NEURONTIN (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-GABAPENTIN | 02293358 | Marketed |
| APO-GABAPENTIN | 02293366 | Marketed |
Medicinal ingredients
- GABAPENTIN 600 MG per TAB
- GABAPENTIN 800 MG per TAB