Product Details
WHO Product ID
TB365
Status
Prequalified
INN, dosage form and strength
Linezolid Tablet, Film-coated 600mg
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
Blister, PVC/Alu
Configuration
10x1, 10x2, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container, protect from light
Packaging Type
Bottle, HDPE
Configuration
30x1, 100x1, 200x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container
Packaging Type
Blister, PVC/PE/PVdC/Alu
Configuration
10x1, 10x2, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Symed Labs Limited (Unit-I)
Survey No 353, Domadugu (Village), Gummadidala (Mandal), Sanga Reddy (Dist)
Telangana
502 313
India
Linezolid
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India