← FDA DRUG APPROVALS

FDA NDA · NDA018413

FUROSEMIDE

Sponsor: CHARTWELL RX

APPLICATION
NDA018413
TYPE
NDA
ORIGINAL APPROVAL
1983-11-30
LATEST ACTION
2015-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FUROSEMIDEDiscontinued
FUROSEMIDE 40MG · TABLET · ORAL
FUROSEMIDEDiscontinued
FUROSEMIDE 20MG · TABLET · ORAL

Approval history

2015-08-07Manufacturing (CMC) · Supplement 62AP
2012-07-11Labeling · Supplement 60 · standardAP
2010-12-27Labeling · Supplement 58AP
2009-03-12Labeling · Supplement 54AP
2009-02-06Labeling · Supplement 49AP
2009-02-06Labeling · Supplement 51AP
2002-10-24Manufacturing (CMC) · Supplement 38AP
2002-07-29Manufacturing (CMC) · Supplement 39AP
2001-09-12Manufacturing (CMC) · Supplement 36AP
2001-04-14Manufacturing (CMC) · Supplement 35AP
2000-02-09Manufacturing (CMC) · Supplement 32AP
2000-02-09Labeling · Supplement 34AP
2000-01-28Manufacturing (CMC) · Supplement 33AP
1999-08-20Manufacturing (CMC) · Supplement 31AP
1999-06-08Manufacturing (CMC) · Supplement 26AP
1999-06-08Manufacturing (CMC) · Supplement 29AP
1999-06-08Manufacturing (CMC) · Supplement 27AP
1999-06-08Manufacturing (CMC) · Supplement 28AP
1999-02-01Manufacturing (CMC) · Supplement 25AP
1998-12-09Manufacturing (CMC) · Supplement 24AP
1998-04-30Manufacturing (CMC) · Supplement 23AP
1997-05-30Manufacturing (CMC) · Supplement 22AP
1995-10-27Manufacturing (CMC) · Supplement 19AP
1993-02-03Manufacturing (CMC) · Supplement 21AP
1992-08-20Manufacturing (CMC) · Supplement 18AP
1992-08-20Manufacturing (CMC) · Supplement 17AP
1992-06-11Labeling · Supplement 20AP
1992-01-07Labeling · Supplement 16AP
1991-06-25Labeling · Supplement 15AP
1988-08-05Labeling · Supplement 13AP
1988-04-25Manufacturing (CMC) · Supplement 12AP
1988-04-25Manufacturing (CMC) · Supplement 10AP
1988-04-25Manufacturing (CMC) · Supplement 11AP
1986-10-15Manufacturing (CMC) · Supplement 5AP
1986-10-15Manufacturing (CMC) · Supplement 3AP
1986-10-15Manufacturing (CMC) · Supplement 4AP
1986-10-15Manufacturing (CMC) · Supplement 2AP
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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