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ANDA 090198b USFDA

Product Details
WHO Product ID
ANDA 090198b USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine Tablet, Film-coated 300mg
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
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India

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