ACETAMINOPHEN | N204767 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| N.D. Ill. | 2013-01-18 | Terminated 2013-03-12 | — | |
| S.D. Cal. | 2013-01-17 | Terminated 2014-08-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius KabiUSA, LLC FDA-2020-P-1246 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition on April 2, 2020, requesting that the FDA designate its Acetaminophen Injection 10 mg/mL, approved under 505(b)(2) NDA 204767, as therapeutically equivalent with an AP rating to the reference listed drug Ofirmev, NDA 022450, by Mallinckrodt Hosp Pr | 505(q) | 2020-04-03 | Denied | Fresenius KabiUSA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8741959 | Apr 19, 2030 | — | — | Yes | — | — |