ACETYLCYSTEINE | A200644 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2012-05-17 | Terminated 2013-11-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley & Lardner LLP FDA-2020-P-1236 · 4 docket documents Foley & Lardner LLP, on behalf of Fresenius Kabi USA LLC, filed a citizen petition under 21 CFR § 10.30 requesting that the FDA designate Acetylcysteine Injection 6gm/30mL (ANDA 200644) as a reference listed drug in the Orange Book to serve as the basis for filing future ANDAs. The petitioner argues | Other | 2020-04-01 | Denied | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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