FUROSEMIDE | N018667 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gland Pharma Limited FDA-2018-P-1720 · 5 docket documents 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 · 8 docket documents 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 | Open | Mylan Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4178
per ml
Lowest NADAC/Unit
$0.3189
per ml
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00409610202FUROSEMIDE 20 MG/2 ML VIAL | $0.4178 | ML | Generic | — | 2026-06-17 |
| 00409610225FUROSEMIDE 20 MG/2 ML VIAL | $0.4178 | ML | Generic | — | 2026-06-17 |
| 00409610204FUROSEMIDE 40 MG/4 ML VIAL | $0.3189 | ML | Generic | — | 2026-06-17 |
| 00409610226FUROSEMIDE 40 MG/4 ML VIAL | $0.3189 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.