Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
PALIPERIDONE | N022043 | JANSSEN LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0775 · 4 docket documents Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that Janssen's 12 mg strength of INVEGA (paliperidone) Extended-release Tablet | 505(q) | 2013-07-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.