Product Details
WHO Product ID
TB285
Status
Prequalified
INN, dosage form and strength
Isoniazid Tablet 300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
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/PVdC/Al
Configuration
10x10; 28x24
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store tablets in the blisters in the provided carton
Packaging Type
Bottle, HDPE
Configuration
30x1, 1000x1 (with desiccant); 30x1, 1000x1 (without desiccant)
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China
Isoniazid
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Aurangabad,
Maharashtra
431 136
India