Approval · Notice of Compliance 13376 · 2012
RANITIDINE: Notice of Compliance 13376
Issued June 8, 2012
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
- 13376
- Date
- June 8, 2012
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Histamine H2 Receptor Antagonist
- Canadian reference product
- ZANTAC (Glaxo Wellcome Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RANITIDINE | 02385953 | Cancelled Post Market |
| RANITIDINE | 02385961 | Cancelled Post Market |
Medicinal ingredients
- RANITIDINE HCL 150 MG per TAB
- RANITIDINE HCL 300 MG per TAB