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TB285

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 Ltd.
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
Packaging Type
Bottle, HDPE
Configuration
30x1, 1000x1 (with desiccant); 30x1, 1000x1 (without desiccant)
Shelf life (months)
24
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
Chhatrapati Sambhajinagar,
Maharashtra
431 136
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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