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ANDA 077695 USFDA

Product Details
WHO Product ID
ANDA 077695 USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine Solution, Oral 10mg/ml
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution, Oral
Reference authority
United States Food and Drug Administration
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
240ml
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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