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NT009

Product Details
WHO Product ID
NT009
Status
Prequalified
INN, dosage form and strength
Ivermectin Tablet 3mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
United States Food and Drug Administration
Applicant organization
Edenbridge Pharmaceuticals LLC
169 Lackawanna Avenue, Suite 110
Parsippany,
N.J. 07054
United States
Packaging details and storage conditions
Packaging Type
Blister, Alu-Alu
Configuration
10x2
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hovione PharmaScience Limited
Estrada Coronel Nicolau de Mesquita
Taipa,
Macao
China
Ivermectin
Zhejiang Hisun Pharmaceutical Co Ltd
46 Waisha Road, Jiaojiang District
Taizhou,
Zhejiang
318 000
China
Ivermectin
FPP Manufacturing Site(s)
Aphena Pharma Solutions - Tennessee, LLC
1920 Fisk Road
Cookeville,
TN 38506
United States
Ingenus Pharmaceuticals NJ, LLC
140 New Dutch Lane
Fairfield,
N.J. 07004
United States
Nurta-Med Packaging Inc
118 Algonquin Parkway
Whippany,
NJ, 07981
United States
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 5 , Part 7

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