Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Approved
Current status date:
2025-01-17
Product name:
BAXDELA
DIN:
02554429
Product Monograph/Veterinary Labelling:
Date:
2025-01-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
XEDITON PHARMACEUTICALS INC
402
2020 Winston Park Drive
Oakville
Ontario
Canada
L6H 6X7
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
08:12.18
Anatomical Therapeutic Chemical (ATC): See footnote 4
J01MA23 DELAFLOXACIN
Active ingredient group (AIG) number:See footnote5
0166464001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DELAFLOXACIN (DELAFLOXACIN MEGLUMINE) | 450 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.