FUROSEMIDE | A202747 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AKORN Specialty Generics FDA-2016-P-2375 AKORN Specialty Generics filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Furosemide Injection 10 mg/mL ANDA 202747 manufactured by Claris as a reference listed drug, enabling AKORN to submit | 505(q) | 2016-08-02 | Open | AKORN Specialty Generics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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