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JULUCA (nda210192)- (EQ 50MG BASE;EQ 25MG BASE)

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE VIIV HLTHCARE
EQ 50MG BASE;EQ 25MG BASE
Yes No
2031-Jan-24 2018-Aug-12
None None
None No
JULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
0 1 0
Total Other Developers 10
Drugs with Suitability No
EQ 50MG BASE;EQ 25MG BASE ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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