AMIODARONE HYDROCHLORIDE | N022325 | BAXTER HEALTHCARE CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-08-29 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0386 Law offices Hyman, Phelps & McNamara, P.C. filed an ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Amiodarone Hydrochloride in Dextrose Injection, 720 mg/400 mL (1.8 mg/mL), suitable for submission in an ANDA, with the refe | Suitability | 2026-01-15 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7635773 | Mar 13, 2029 | — | — | Yes | — | — |
Baxter Healthcare added U.S. Patent 10,117,951 to the Orange Book listing for Nexterone (amiodarone hydrochloride) NDA 022325.
New: New record
BAXTER HEALTHCARE added U.S. Patent 10,117,951 to the Orange Book listing for Nexterone (amiodarone hydrochloride) NDA 022325.
New: New record