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HA645

Product Details
WHO Product ID
HA645
Status
Prequalified
INN, dosage form and strength
Dapsone Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
United States Food and Drug Administration
Applicant organization
Everest Life Sciences LLC
8 Sheller Drive
Monroe,
New Jersey
08831-8402
United States of America
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/TE/PVdC
Configuration
15x2
Shelf life (months)
60
Storage conditions
Do not store above 25°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Jacobus Pharmaceutical Co Inc
IRL Building, Schalks Crossing Road
Plainsboro,
8536
United States of America
Dapsone
FPP Manufacturing Site(s)
Future Pak
28115 Lakeview Drive
Wixom,
MI 48393
United States of America
Jacobus Pharmaceutical Co Inc
IRL Building, Schalks Crossing Road
Plainsboro,
8536
United States of America
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2a , Part 2b , Part 4 , Part 5 , Part 7

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