WHO Product ID
NDA 210865 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir alafenamide Tablet 50mg/300mg/25mg
Date of prequalification
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
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
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
Packaging Type
Bottle, HDPE
Configuration
90x1,
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
Packaging Type
Bottle, HDPE
Configuration
180x1
Shelf life (months)
12
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India