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ANDA 091475 USFDA

Product Details
WHO Product ID
ANDA 091475 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
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
240ml
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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