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 PALMITATE | A216674 | ACCORD HLTHCARE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
JANSSEN PHARMACEUTICALS, INC. et al v. ACCORD HEALTHCARE, INC. 1 patentANDA 216674paliperidone palmitate extended-release injectable suspension | D.N.J. | 2022-02-16 | Terminated 2022-07-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.