Product Details
WHO Product ID
ANDA 090513 USFDA
Status
Prequalified
INN, dosage form and strength
Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/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
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
FPP Manufacturing Site(s)
Aurobindo Pharma Ltd
Unit 3, Survey No 313, Bachupally, Quthubllaur (M), Rangareddy District
Hyderabad,
Andhra Pradesh
500 072
India