Product Details
WHO Product ID
NDA 211912 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
Celltrion Inc.
23 Academy-ro,, Yeonsu-gu
Incheon,
22014
Republic of Korea
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Aizant Drug Research Solutions Pvt. Ltd
Block No. B, Sy. No. 172 & 173, Apparel Park Rd., Dulapally Village, Medchal-Malkhajgiri District
Dundigal-Gandimaisamma Mandal,
Telangana
India
CELLTRION PHARM, Inc.
82, 2 Sandan-ro, Ochang-eup, Cheongwon-gu
Cheongju-si,
28117
Republic of Korea