FUROSEMIDE | N018579 | AMERICAN REGENT INC
| 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 |
Citizen Petition from ANDA Consultants FDA-2016-P-2091 ANDA Consultants filed this citizen petition requesting that the FDA Commissioner determine whether Furosemide Injection, 10 mg/mL, manufactured by Luitpold under NDA 018579, was voluntarily withdrawn from sale for safety or effectiveness reasons, as the drug is currently listed in the discontinued | Other | 2016-07-16 | Open | ANDA Consultants |
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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