Product Details
WHO Product ID
ANDA 090309 USFDA
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/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
Mylan Laboratories Ltd
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
24
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India