WHO Product ID
ANDA 219623 USFDA
Status
Acceptable
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine null 50mg/300mg
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
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
Shelf life (months)
36
Storage conditions
Do not store above 30°C
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