Approval · Notice of Compliance 15517 · 2014
DIFICID: Notice of Compliance 15517
Issued March 24, 2014
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
- 15517
- Date
- March 24, 2014
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to criteria for butylated hydroxytoluent (bht) in release and shelf-life speicifications for tablets
- Therapeutic class
- Antibacterial agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DIFICID | Not yet assigned | — |
Medicinal ingredients
- FIDAXOMICIN 200 MG per TAB