VARENICLINE TARTRATE | N021928 | PF PRISM CV
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-09-30 | Terminated 2021-10-19 | — | |
| S.D.N.Y. | 2019-01-22 | Terminated 2019-03-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Medley Pharmaceuticals Ltd. FDA-2022-P-1013 Medley Pharmaceuticals Ltd. filed this citizen petition pursuant to FDC Act Section 505(j) and 21 CFR Section 314.122 and 314.161 requesting that the FDA determine whether Chantix (Varenicline Tartrate) Tablets 0.5 mg and 1 mg, approved under NDA 021928 and held by PF PRISM CV, was not withdrawn for | 505(q) | 2022-06-06 | Denied | Medley Pharmaceuticals Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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