Product Details
WHO Product ID
NDA 209618 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
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
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1, 180x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
APL Healthcare Limited
Unit-IV, Plot No 16, APIIC Multi products SEZ, Menakur Village, Naidupeta Mandal, S.P.S.R Nellore District
Andhra Pradesh
India
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