Product Details
WHO Product ID
NDA 207315 USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 75mg/75mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
301
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India