← FDA DRUG APPROVALS

FDA NDA · NDA209988

FUROSCIX

furosemide injection 80 mg/ 10 ml

Sponsor: SCPHARMACEUTICALS

APPLICATION
NDA209988
TYPE
NDA
ORIGINAL APPROVAL
2022-10-07
LATEST ACTION
2026-07-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FUROSCIX · ReferencePrescription
FUROSEMIDE 80MG/10ML (8MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-07-23Efficacy · Supplement 7 · standard — Label ↗AP
2025-12-22Efficacy · Supplement 4 · standard — Letter ↗AP
2025-03-06Efficacy · Supplement 3 · standard — Letter ↗AP
2024-08-09Efficacy · Supplement 1 · standard — Label ↗AP
2022-10-07Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

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