Approval · Notice of Compliance 36146 · 2025
PEPCID COMPLETE: Notice of Compliance 36146
Issued October 10, 2025
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
- 36146
- Date
- October 10, 2025
- Company
- McNeil Consumer Healthcare, division of Johnson & Johnson Inc.Markham, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Change in the manufacturing process for the drug substance. Change in the specification for the drug substance. Update to package labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PEPCID COMPLETE | Not yet assigned | — |
Medicinal ingredients
- CALCIUM CARBONATE 800 MG per TAB
- FAMOTIDINE 10 MG per TAB
- MAGNESIUM HYDROXIDE 165 MG per TAB