Skip to main content

HA716

Product Details
WHO Product ID
HA716
Status
Prequalified
INN, dosage form and strength
Ciprofloxacin Tablet, Film-coated 250mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
Unique Pharmaceutical Laboratories (Mumbai)
Neelam Centre, Bwing 4th Floor, Hind Cycle Road, Worli
Mumbai,
Maharashtra
400030
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
50x1, 100x1, 500x1
Shelf life (months)
48
Storage conditions
Do store above 25°C, excursions permitted to 15°C and 30°C. Avoid excursions ove
API Manufacturing Site(s)
By Organization
By Active Ingredient
Neuland Laboratories Limited
Plot Nos: 92, 93, 94, 257, 258, 259, IDA, Pashamylaram, Patancheru Mandal, Medak District
Isnapur,
Telangana
502319
India
Ciprofloxacin (hydrochloride)
FPP Manufacturing Site(s)
Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd)
Plot No. 215-219, GIDC Industrial area, Panoli, Bharuch
Gujarat,
394116
India
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 3 , Part 4 , Part 5 , Part 7

.