Medicines/finished pharmaceutical products

Reference Number: 
NDA 22295 USFDA

Basis of listing: 
USFDA
Status: 
Active
INN: 
Abacavir (sulfate)/Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 60mg/30mg
Packaging: 
Bottle HDPE: 30x1, 60x1; Blister Alu/PVC/PE/PVdC: 10x10
Applicant: 
Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India
FPP Manufacturing Site: 

Aurobindo Pharma Ltd, Unit 3, Survey No 313, Bachupally, Hyderabad, Quthubllaur (M), Rangareddy District, Andhra Pradesh, 500 072, India