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FDA NDA · NDA018487

FUROSEMIDE

Sponsor: PHARMOBEDIENT

APPLICATION
NDA018487
TYPE
NDA
ORIGINAL APPROVAL
1981-08-27
LATEST ACTION
2016-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2016-03-08Labeling · Supplement 43 · standard — Label ↗AP
2010-02-12Manufacturing (CMC) · Supplement 40 — Letter ↗AP
2008-11-04Labeling · Supplement 38AP
2001-09-25Manufacturing (CMC) · Supplement 32AP
2001-09-25Manufacturing (CMC) · Supplement 31AP
1998-12-07Manufacturing (CMC) · Supplement 30AP
1998-02-25Manufacturing (CMC) · Supplement 29AP
1998-02-05Manufacturing (CMC) · Supplement 28AP
1997-10-06Labeling · Supplement 27AP
1996-04-29Labeling · Supplement 26AP
1994-01-07Manufacturing (CMC) · Supplement 25AP
1993-06-15Labeling · Supplement 24AP
1993-04-13Labeling · Supplement 22AP
1992-05-06Labeling · Supplement 21AP
1992-03-18Labeling · Supplement 20AP
1990-12-27Labeling · Supplement 19AP
1990-07-05Labeling · Supplement 18AP
1989-10-13Labeling · Supplement 13AP
1989-09-19Manufacturing (CMC) · Supplement 16AP
1988-03-01Manufacturing (CMC) · Supplement 14AP
1988-03-01Manufacturing (CMC) · Supplement 15AP
1985-01-09Manufacturing (CMC) · Supplement 7AP
1981-08-27OriginalAP
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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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