Reference Number: ANDA 078545 USFDA 2
Reference Number:
ANDA 078545 USFDA 2Basis of listing:
USFDAStatus:
Active
INN:
LamivudineTherapeutic area:
HIV/AIDSDosage form & strength:
Tablet 300mg
Packaging:
Blister 10x1; Bottle, HDPE 60x1
Applicant:
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site:
Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India