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ANDA 090688 USFDA

Product Details
WHO Product ID
ANDA 090688 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
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVdC/PVC
Configuration
10x6, 10x12
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
60
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India

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