Medicines/finished pharmaceutical products

Reference Number: 
NDA 210787 USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg/300mg/300mg
Packaging: 
Bottle, HDPE 30x1, 90x1
Applicant: 
Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India
FPP Manufacturing Site: 

Laurus Labs Ltd, (Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal,Visakhapatnam-District, Andhra Pradesh, 531011, India