FUROSEMIDE | A070433 | 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Oral Solution 40 mg/5 mL (ANDA070433) manufactured by Hikma Pharmaceuticals USA Inc as Ref | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |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.
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