Approval · Notice of Compliance 8394 · 2006
SEPTRA: Notice of Compliance 8394
Issued November 7, 2006
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
- 8394
- Date
- November 7, 2006
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updated product monograph including indication, treatment duration, pharmacokinetics and safety information
- Therapeutic class
- Antibacterial agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SEPTRA | Not yet assigned | — |
Medicinal ingredients
- SULFAMETHOXAZOLE 80 MG per ML
- TRIMETHOPRIM 16 MG per ML