FUROSEMIDE | A070434 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quagen Pharmaceuticals LLC FDA-2025-P-4046 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Oral Solution 40 mg/5 mL (ANDA070433) manufactured by Hikma Pharmaceuticals USA Inc as Ref | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |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
$0.0934
per ml
Lowest NADAC/Unit
$0.0934
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 | $0.0934 | ML | Generic | — | 2026-10-21 |
| 00054329446FUROSEMIDE 10 MG/ML SOLUTION | $0.0934 | ML | Generic | — | 2026-10-21 |
| 00054329450FUROSEMIDE 10 MG/ML SOLUTION | $0.0934 | ML | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.