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ANDA 078128 USFDA

Product Details
WHO Product ID
ANDA 078128 USFDA
Status
Prequalified
INN, dosage form and strength
Zidovudine Capsules, hard 100mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
United States Food and Drug Administration
Applicant organization
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
Packaging details and storage conditions
Packaging Type
Blister
Configuration
10x1
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
100x1
Shelf life (months)
24
FPP Manufacturing Site(s)
Aurobindo Pharma Ltd
Unit 3, Survey No 313, Bachupally, Quthubllaur (M), Rangareddy District
Hyderabad,
Andhra Pradesh
500 072
India

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