Testing version — LOERadar is in active testing. Features and data may change.
FAZACLO ODT (CLOZAPINE) | LOERadar
FAZACLO ODT
NDA
CLOZAPINE | N021590 | JAZZ PHARMACEUTICALS IRELAND LTD
6 strengths0 unique patents0 unique exclusivities
PTAB Proceedings
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 (6)
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#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▴
TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Feb 10, 2004
No patent or exclusivity listings for this strength.
#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Feb 10, 2004
#003 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 3, 2005
#004 — 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 30, 2007
#005 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**