Medicines/finished pharmaceutical products

Reference Number: 
NDA 209618 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
Applicant: 
Aurobindo Pharma Ltd, Unit VII, SEZ, APIIC Plot No SI, Survey No 411, 425, 434, 435 and 458, Green Industrial Park, Village Polepally, Mandal Jedcherla, District Mahaboobnagar, Andhra Pradesh, India
FPP Manufacturing Site: 

Aurobindo Pharma Ltd, Unit VII, SEZ, APIIC Plot No SI, Survey No 411, 425, 434, 435 and 458, Green Industrial Park, Village Polepally, Mandal Jedcherla, District Mahaboobnagar, Andhra Pradesh, India