Product Details
WHO Product ID
NDA 217070 USFDA
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
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
1 x 90, 1 x 180
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