Product Details
WHO Product ID
ANDA 210642 USFDA
Status
Acceptable
INN, dosage form and strength
Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg
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
Shelf life (months)
36
Storage conditions
Do not store above 30°C
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