Medicines/finished pharmaceutical products

Reference Number: 
ANDA 078850a USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg
Packaging: 
Bottle HDPE: 60x1; Blister Alu/PVC: 10x1
Applicant: 
Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
Stada-VN Joint Venture Co. Ltd, Binh Duong Branch, 40 Tu Do Avenue, Viet-Nam Singapore Industrial Park, Thuan An, Viet Nam