Approval · Notice of Compliance 32305 · 2023
PREGABALIN: Notice of Compliance 32305
Issued December 6, 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
- 32305
- Date
- December 6, 2023
- Company
- Alembic Pharmaceuticals LimitedVadodara, Gujarat, India
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Update to the Package Insert
- Canadian reference product
- LYRICA (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREGABALIN | 02416689 | Approved |
| PREGABALIN | 02416697 | Approved |
| PREGABALIN | 02416700 | Approved |
| PREGABALIN | 02416719 | Approved |
| PREGABALIN | 02416727 | Approved |
| PREGABALIN | 02416735 | Approved |
| PREGABALIN | 02416743 | Approved |
| PREGABALIN | 02416751 | Approved |
Medicinal ingredients
- PREGABALIN 25 MG per CAP
- PREGABALIN 50 MG per CAP
- PREGABALIN 75 MG per CAP
- PREGABALIN 100 MG per CAP
- PREGABALIN 150 MG per CAP
- PREGABALIN 200 MG per CAP
- PREGABALIN 225 MG per CAP
- PREGABALIN 300 MG per CAP