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DELSTRIGO (nda210807)- (100MG;300MG;300MG)

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MSD MERCK CO
100MG;300MG;300MG
Yes Yes
2036-Nov-29 2023-Aug-30
None None
None No
DELSTRIGO is a three-drug combination of doravirine (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: • with no antiretroviral treatment history, OR • 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 with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.
0 1 0
Total Other Developers 3
Drugs with Suitability No
100MG;300MG;300MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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