POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | N218343 | AMNEAL EU LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Nivagen Pharmaceuticals, Inc. v. Amneal Pharmaceuticals Inc. et al 2 patentsPotassium phosphates in sodium chloride | D. Del. | 2024-07-19 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Sagent Pharmaceuticals FDA-2025-P-6894 Sagent Pharmaceuticals submitted this Section 505(j)(2)(C) suitability petition requesting FDA approval to file an ANDA for Potassium Phosphates in 0.9% Sodium Chloride Injection at a new strength of phosphorus 30 mmol/500 mL and potassium 44 mEq/500 mL, based on the reference listed drug NDA 218343 | Suitability | 2025-12-10 | Open | Sagent Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.