WHO Product ID
NDA 219804 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50 mg/300 mg/300 mg
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Aspen SA Operations (Pty) Ltd
PO Box 4002, Korsten
Gqeberha,
6014
South Africa
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Aspen SA Operations (Pty) Ltd
7 Fairclough Road, Korsten
Gqeberha,
Oos-Kaap
6020
South Africa