Product Details
WHO Product ID
NDA 207369 USFDA
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg
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
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Packaging Type
Blister, Alu/Alu
Configuration
10x10
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