Medicines/finished pharmaceutical products

Reference Number: 
NDA 207369 USFDA 2

Basis of listing: 
USFDA
Status: 
Active
INN: 
Abacavir (sulfate)/Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 60mg/30mg
Packaging: 
Blister, Alu/Alu 10x10; Bottle, HDPE 30x1
Applicant: 
Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India