FUROSEMIDE | N018902 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mylan Pharmaceuticals Inc FDA-2016-P-1285 Mylan Pharmaceuticals Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Furosemide Injection, USP—10 mg/mL in 2 mL, 4 mL, and 10 mL fill suitable for submission as an ANDA, with designation of either Fresenius | Other | 2016-05-19 | Denied | Mylan Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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