Product Details
WHO Product ID
NDA 214566 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Dispersible 10mg
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
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 90, 1 x 180 (with desiccant), 1 x 90, 1 x 180 (without desiccant)
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