FUROSEMIDE | A070433 | 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Oral Solution 40 mg/5 mL (ANDA070433) manufactured by Hikma Pharmaceuticals USA Inc as Ref | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |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.
No patent or exclusivity listings for this strength.