Approval · Notice of Compliance 18402 · 2016
TUSSIONEX: Notice of Compliance 18402
Issued August 23, 2016
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
- 18402
- Date
- August 23, 2016
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the hydrocodone bitartrate drug substance manufacturing process and manufacturing, release testing, and packaging stability testing sites
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TUSSIONEX | Not yet assigned | — |
Medicinal ingredients
- PHENYLTOLOXAMINE CITRATE 10 MG per TAB
- HYDROCODONE BITARTRATE 5 MG per TAB
- PHENYLTOLOXAMINE 10 MG per 5ML
- HYDROCODONE BITARTRATE 5 MG per 5ML