Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
NDATentative Approval
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE | N212527 | CIPLA USA INC.
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (1)
#001 — EQ 50MG BASE; 300MG; 25MG
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TABLET | TA Date: 2022-03-30 00:00:00
No patent or exclusivity listings for this strength.