Approval · Notice of Compliance 634 · 2002
LEVAQUIN: Notice of Compliance 634
Issued December 11, 2002
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
- 634
- Date
- December 11, 2002
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indication (tablets 250mg, 500mg, 750mg; injection 25mg/ml, 5mg/ml in 5% dextrose): complicated skin and skin structure infections (mild to moderate), excluding burns, due to enterococcus faecalis, methicillin-sensitive staphylococcus aureus, streptococcus pyogenes, proteus mirabilis, or streptococcus agalactiae; new dosing regimen of 750mg once daily for treatment of complicated skin and skin structure infections
- Therapeutic class
- Antibacterial agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LEVAQUIN | 02246804 | Cancelled Post Market |
| LEVAQUIN | Not yet assigned | — |
Medicinal ingredients
- LEVOFLOXACIN 250 MG per TAB
- LEVOFLOXACIN 500 MG per TAB
- LEVOFLOXACIN 750 MG per TAB
- LEVOFLOXACIN 5 MG per ML
- LEVOFLOXACIN 25 MG per ML