No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (5)
Sort:
#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▴
TABLET, CHEWABLE;ORAL | Approved: Nov 16, 2007
No patent or exclusivity listings for this strength.
#004 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET, CHEWABLE;ORAL | Approved: Nov 16, 2007
#007 — 2.5MG
RLD
0 patents0 exclusivities▾
TABLET, CHEWABLE;ORAL | Approved: Nov 30, 2020
#005 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET, CHEWABLE;ORAL | Approved: Nov 16, 2007
#006 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**