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NDA 22461b USFDA

Product Details
WHO Product ID
NDA 22461b USFDA
Status
Prequalified
INN, dosage form and strength
Efavirenz Tablet, Film-coated 100mg
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
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Shelf life (months)
24
Storage conditions
Do not store above 25°C
Packaging Type
Bottle, HDPE
Shelf life (months)
24

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