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ANDA 077464a USFDA

Product Details
WHO Product ID
ANDA 077464a USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine Tablet 150mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
United States Food and Drug Administration
Applicant organization
Aurobindo Pharma Ltd
Unit 3, Survey No 313, Bachupally, Quthubllaur (M), Rangareddy District
Hyderabad,
Andhra Pradesh
500 072
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
24
Packaging Type
Blister
Configuration
10x1
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

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