FUROSEMIDE | N018667 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gland Pharma Limited FDA-2018-P-1720 Gland Pharma Limited filed this citizen petition on May 2, 2018 under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA amend the Orange Book to designate Furosemide Injection 10 mg/mL (NDA #N018667 held by Hospira) as the reference stan | 505(q) | 2018-05-02 | Open | Gland Pharma Limited |
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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