Product Details
WHO Product ID
ANDA 205412 USFDA
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu; Blister, Alu/PVC/PVdC
Configuration
10
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
FPP Manufacturing Site(s)
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