WHO Product ID
NDA 210796 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
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
1 x 30, 1 x 90, 1 x 180
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Macleods Pharmaceutical limited
Plot No. M-50 to M-54-A, Indore Special Economic Zone, Phase II, Dist. Dhar
Pithampur,
Madhya Pradesh
454774
India
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India