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FDA NDA · NDA018667

FUROSEMIDE

Sponsor: HOSPIRA

APPLICATION
NDA018667
TYPE
NDA
ORIGINAL APPROVAL
1982-05-28
LATEST ACTION
2024-10-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FUROSEMIDEPrescription
FUROSEMIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2024-10-01Labeling · Supplement 48 · standard — Letter ↗AP
2022-08-31Labeling · Supplement 43 · standard — Label ↗AP
2016-09-22Labeling · Supplement 36 · standard — Label ↗AP
2012-05-10Labeling · Supplement 34 · standardAP
2002-10-25Manufacturing (CMC) · Supplement 19AP
2001-03-22Manufacturing (CMC) · Supplement 18AP
2001-03-22Manufacturing (CMC) · Supplement 17AP
2000-01-07Labeling · Supplement 16AP
2000-01-07Manufacturing (CMC) · Supplement 15AP
1997-05-12Labeling · Supplement 14AP
1996-10-03Manufacturing (CMC) · Supplement 13AP
1994-01-27Labeling · Supplement 9AP
1993-03-09Labeling · Supplement 8AP
1992-07-09Labeling · Supplement 7AP
1988-06-16Labeling · Supplement 6AP
1988-01-20Manufacturing (CMC) · Supplement 5AP
1988-01-20Manufacturing (CMC) · Supplement 3AP
1988-01-20Manufacturing (CMC) · Supplement 1AP
1982-05-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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