Product Details
WHO Product ID
NDA 215448 USFDA
Status
Acceptable
INN, dosage form and strength
Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
24
FPP Manufacturing Site(s)
APL Healthcare Limited
Unit-IV, Plot No 16, APIIC M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District
Andhra Pradesh
524421
India