Medicines/finished pharmaceutical products

Reference Number: 
NDA 210880 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 30, 60, 90, 100, 750
Applicant: 
Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India