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ANDA 21988 USFDA

Product Details
WHO Product ID
ANDA 21988 USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine/Zidovudine Tablet + Nevirapine Tablet 150mg/300mg + 200mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet + Tablet
Reference authority
United States Food and Drug Administration
Applicant organization
Strides Pharma Science Limited
Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road
Bangalore,
Karnataka
560 076
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
0
Storage conditions
Do not store above 25°C
FPP Manufacturing Site(s)
Strides Pharma Science Limited
Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk
Bangalore,
Karnataka
562 106
India

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