药品/药物成品

Reference Number: 
ANDA 208355 USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Dolutegravir (Sodium)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 50mg
Packaging: 
Bottle, HDPE 30x1, 90x1
Applicant: 
Aurobindo Pharma Ltd, Plot No 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, 500 038, 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