VASOPRESSIN | N217569 | BAXTER HEALTHCARE CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation 3 patentsvasopressin | D. Del. | 2023-03-29 | Terminated 2025-02-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Fresenius Kabi USA, LLC FDA-2024-P-4135 Fresenius Kabi USA, LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Vasopressin in 0.9% Sodium Chloride Injection 50 units per 50 mL (1 unit/mL) in a single dose ready | Suitability | 2024-08-29 | Open | Fresenius Kabi USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12447190 | Sep 27, 2044 | — | — | Yes | — | — |