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NT019

Product Details
WHO Product ID
NT019
Status
Prequalified
INN, dosage form and strength
Azithromycin Tablet, Film-coated 500mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
ACI HealthCare Limited
Sonargaon Museum Gate-1 Road, Treepordi
Sonargaon,
Narayanganj
1440
Bangladesh
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 500x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Jiangsu Weiqida Pharmaceutical Co Ltd
No. 1 Linjiang Avenue, Linjiang Town, Haimen District
Nantong,
Jiangsu
226133
China
Azithromycin
FPP Manufacturing Site(s)
ACI HealthCare Limited
Sonargaon Museum Gate-1 Road, Treepordi
Sonargaon,
Narayanganj
1440
Bangladesh
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 7

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