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ANDA 203759 USFDA

Product Details
WHO Product ID
ANDA 203759 USFDA
Status
Prequalified
INN, dosage form and strength
Ritonavir Tablet 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
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in the original container
FPP Manufacturing Site(s)
Cipla
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India

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