METHYLPHENIDATE HYDROCHLORIDE | N202100 | NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Tris Pharma Inc. v. Par Pharmaceutical Inc. et al 5 patentsANDA 206926methylphenidate hydrochloride (methylphenidate HCl) | D. Del. | 2015-01-21 | Terminated 2015-11-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer, Inc. FDA-2014-P-1269 Pfizer, Inc. filed this petition requesting that the FDA establish partial AUC metrics, specifically AUC (0-3) and AUC (3-t) in both fasted and fed states, as the appropriate bioequivalence standards for any ANDA product proposing to demonstrate therapeutic equivalence to Quillivant XR, a modified-r | 505(q) | 2014-08-28 | Partially Denied | Pfizer |
Source: Regulations.gov. FDA citizen petitions matched by application number.