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FDA NDA · NDA018579

FUROSEMIDE

Sponsor: AM REGENT

APPLICATION
NDA018579
TYPE
NDA
ORIGINAL APPROVAL
1983-11-30
LATEST ACTION
2024-10-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FUROSEMIDE · ReferenceDiscontinued
FUROSEMIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-10-01Labeling · Supplement 34 · standard — Letter ↗AP
2022-03-30Manufacturing (CMC) · Supplement 33 — Letter ↗AP
2014-06-27Manufacturing (CMC) · Supplement 30AP
2011-08-16Labeling · Supplement 29 — Label ↗AP
2002-07-15Manufacturing (CMC) · Supplement 20AP
2002-06-27Manufacturing (CMC) · Supplement 23AP
2002-06-27Manufacturing (CMC) · Supplement 21AP
2002-06-27Labeling · Supplement 22AP
2000-12-04Manufacturing (CMC) · Supplement 19AP
2000-12-04Manufacturing (CMC) · Supplement 17AP
2000-12-04Manufacturing (CMC) · Supplement 18AP
1997-07-08Manufacturing (CMC) · Supplement 15AP
1997-05-21Labeling · Supplement 16AP
1996-02-28Manufacturing (CMC) · Supplement 14AP
1993-06-07Labeling · Supplement 13AP
1992-12-29Manufacturing (CMC) · Supplement 12AP
1992-04-14Labeling · Supplement 11AP
1991-08-22Labeling · Supplement 10AP
1989-08-15Manufacturing (CMC) · Supplement 7AP
1989-08-15Manufacturing (CMC) · Supplement 8AP
1989-08-15Manufacturing (CMC) · Supplement 9AP
1989-02-14Manufacturing (CMC) · Supplement 4AP
1988-10-07Labeling · Supplement 6AP
1983-11-30OriginalAP
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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