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ANDA 078850a USFDA

Product Details
WHO Product ID
ANDA 078850a USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine Tablet, Film-coated 150mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
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
60, 600
Shelf life (months)
24
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India

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