POTASSIUM CHLORIDE | N206814 | GENUS LIFE SCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Buchanan Ingersoll & Rooney PC (Virtus Pharmaceuticals... FDA-2016-P-2029 Buchanan Ingersoll & Rooney PC, on behalf of Virtus Pharmaceuticals OpCo, LLC, filed this citizen petition under 505(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA institute proceedings to withdraw two New Drug Applications—NDA 208019 for Potassium Chloride for Oral Solution | Other | 2016-07-13 | Denied | Buchanan Ingersoll & Rooney PC (Virtus Pharmaceuticals OpCo |
Citizen Petition from PAR Pharmaceutical FDA-2016-P-1073 Par Pharmaceutical (Generics Bidco I, LLC) filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refrain from approving any Abbreviated New Drug Application for a Potassium Chloride Oral Solution containing alcohol as an inactive ingredient | 505(q) | 2016-03-30 | Denied | PAR Pharmaceutical |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12539314 | Mar 7, 2039 | — | — | Yes | — | — |