Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
PALIPERIDONE | N022043 | JANSSEN LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0775 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.