Product Details
WHO Product ID
TB286
Status
Prequalified
INN, dosage form and strength
Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
100x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, PVC/PVdC/Alu
Configuration
10x1; 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Ltd
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Moxifloxacin (hydrochloride)
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India