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 (2)
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#001 — 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▴
TABLET;ORAL-21 | Approved: Oct 9, 1996
No patent or exclusivity listings for this strength.
#002 — 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**