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 (7)
Sort:
#007 — 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▴
TABLET;ORAL | Approved: Feb 13, 1996
No patent or exclusivity listings for this strength.
#012 — 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET;ORAL | Approved: Aug 31, 2000
#013 — 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET;ORAL | Approved: Aug 31, 2000
#008 — 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET;ORAL | Approved: Feb 13, 1996
#010 — 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET;ORAL | Approved: May 12, 1997
#009 — 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET;ORAL | Approved: May 12, 1997
#011 — 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**