FUROSEMIDE | A070434 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quagen Pharmaceuticals LLC FDA-2025-P-4046 · 3 docket documents Quagen Pharmaceuticals LLC filed this petition pursuant to section 505(j) of the FDC Act requesting that the FDA amend the Orange Book to designate Furosemide Oral Solution 10 mg/mL (ANDA070434) and Furosemide Oral Solution 40 mg/5 mL (ANDA070433) manufactured by Hikma Pharmaceuticals USA Inc as Ref | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0916
per ml
Lowest NADAC/Unit
$0.0916
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68094075662FUROSEMIDE 40 MG/4 ML ORAL SOLUTION CUP | $0.0916 | ML | Generic | — | 2026-06-17 |
| 00054329446FUROSEMIDE 10 MG/ML SOLUTION | $0.0916 | ML | Generic | — | 2026-06-17 |
| 00054329450FUROSEMIDE 10 MG/ML SOLUTION | $0.0916 | 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.