Medicines/finished pharmaceutical products

Reference Number: 
ANDA 078742 USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Abacavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage 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