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PREZCOBIX (nda205395)- (150MG;800MG)

COBICISTAT; DARUNAVIR JANSSEN PRODS
150MG;800MG
Yes No
2032-Oct-06 2017-Aug-27
None None
None No
PREZCOBIX is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatmentnaïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
0 1 0
Total Other Developers 4
Drugs with Suitability No
150MG;800MG ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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