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NDA 205508 USFDA

Product Details
WHO Product ID
NDA 205508 USFDA
Status
Prequalified
INN, dosage form and strength
Atazanavir (sulfate)/Ritonavir Tablet 300mg/100mg
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
Emcure Pharmaceuticals Limited
Plot No. P1 & P2, I.T.B.T. Park Phase II., M.I.D.C., Hinjawadi
Pune,
Maharashtra
411057
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
FPP Manufacturing Site(s)
Emcure Pharmaceuticals Ltd
Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjawadi
Pune,
Maharashtra
411057
India

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