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NDA 21837 USFDA

Product Details
WHO Product ID
NDA 21837 USFDA
Status
Prequalified
INN, dosage form and strength
Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg
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
Strides Pharma Global PTE Limited
1 Gateway Drive, #06-06 Westgate Tower
608531
Singapore
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
24
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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