NITRIC OXIDE | A207141 | VERO BIOTECH INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Mallinckrodt Hospital Products IP Ltd. et al v. Praxair Distribution Inc. et al 10 patentsANDA 207141nitric oxide | D. Del. | 2015-02-19 | Terminated 2019-12-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mallinckrodt Pharmaceuticals FDA-2016-P-1955 Mallinckrodt Pharmaceuticals filed this citizen petition on June 30, 2016, requesting that the FDA designate INOMAX (nitric oxide) 800 ppm for inhalation and its associated INOmax DS Plus delivery system as a drug-device combination product, and refuse approval of any NDA or ANDA for follow-on inhal | 505(q) | 2016-07-08 | Denied | Mallinckrodt Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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