FULVESTRANT | N210326 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-12-14 | Terminated 2018-01-22 | — | |
| D.N.J. | 2017-12-14 | Terminated 2018-02-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2022-P-0287 · 3 docket documents Fresenius Kabi USA, LLC filed this petition requesting that the FDA designate its Neostigmine Methylsulfate Injection, approved under 505(b)(2) NDA 203629, as therapeutically equivalent with an AB rating to the reference listed drug Bloxiverz (NDA 204078). The petitioner argues that its product is p | Other | 2022-03-04 | Open | Fresenius Kabi USA, LLC |
Citizen Petition from Fresenius Kabi USA, LLC FDA-2019-P-2590 · 4 docket documents Fresenius Kabi USA, LLC filed this petition requesting that the FDA designate its Fulvestrant Injection, 50 mg/mL, approved under 505(b)(2) NDA 210326, as therapeutically equivalent with an AB rating to the reference listed drug Faslodex (NDA 021344) manufactured by Astrazeneca Pharmaceuticals LP. T | 505(q) | 2019-05-29 | Withdrawn | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.