Product Details
WHO Product ID
ANDA 091144 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
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Packaging Type
Blister
Configuration
10x3
Shelf life (months)
24
FPP Manufacturing Site(s)
Cipla Ltd
Unit 1, Plot A-33, A-37 & A-2 MIDC Industrial Area, Raigad District
Patalganga,
Maharashtra
410 220
India