CALCIUM GLUCONATE | N208418 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
HQ Specialty Pharma Corp. et al v. Cipla Ltd. et al 1 patentANDA 217891calcium gluconate in sodium chloride | D. Del. | 2025-10-07 | Active | — |
HQ Specialty Pharma Corp. et al v. Sagent Pharmaceuticals 1 patentANDA 219619calcium gluconate in sodium chloride | D. Del. | 2025-10-03 | Active | — |
HQ Specialty Pharma Corp. et al v. Amneal Pharmaceuticals LLC 1 patentANDA 217174calcium gluconate in sodium chloride | D. Del. | 2023-10-11 | Terminated 2025-08-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA LLC FDA-2022-P-0290 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition requesting that the FDA designate its Calcium Gluconate in Sodium Chloride Injection 1g/50mL and 2g/100mL, approved under NDA 208418 via 505(b)(2), as therapeutically equivalent with an AP rating to HQ Specialty Pharma Corp's Calcium Gluconate in S | Other | 2022-03-04 | Withdrawn | Fresenius Kabi USA LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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