WHO Product ID
NDA 211868 USFDA
Status
Prequalified
INN, dosage form and strength
Dolutegravir (Sodium), Lamivudine and Tenofovir Disoproxil Fumarate Tablet, 50 mg/300 mg/300 mg
Date of prequalification
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Emcure Pharmaceuticals Limited
Plot No. P1 & P2, I.T.B.T. Park Phase II., M.I.D.C., Hinjawadi
Pune,
Maharashtra
411057
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1, 180x1
Shelf life (months)
36
FPP Manufacturing Site(s)
Emcure Pharmaceuticals Limited
New Survey No. 485, (Old Survey No. 160/P-1), Village-Kadu, Taluka-Lakhtar,
Surendranagar,
Gujarat
382775
India
Milan Laboratories (India) Private Limited
Plot No. Z-96/A, Dahej SEZ Phase– 2,
Bharuch,
Gujarat
392130
India