APPLICATION
ANDA203428
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-26
LATEST ACTION
2025-09-08
ROUTE
INTRAVENOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FUROSEMIDEPrescription
FUROSEMIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2025-09-08Labeling · Supplement 31 · standardAP
2018-03-05Manufacturing (CMC) · Supplement 8 · unknownAP
2014-08-26UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.