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ANDA 078887 USFDA

Product Details
WHO Product ID
ANDA 078887 USFDA
Status
Prequalified
INN, dosage form and strength
Nevirapine Tablet 200mg
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 Ltd
Emcure House, T-184, M.I.D.C., Bhosari, Pune
411026
India
Packaging details and storage conditions
Packaging Type
Blister
Configuration
10x1
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
60x1
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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