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FDA NDA · NDA018823

FUROSEMIDE

Sponsor: HIKMA

APPLICATION
NDA018823
TYPE
NDA
ORIGINAL APPROVAL
1983-11-10
LATEST ACTION
2017-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FUROSEMIDEPrescription
FUROSEMIDE 20MG · TABLET · ORAL
FUROSEMIDEPrescription
FUROSEMIDE 40MG · TABLET · ORAL

Approval history

2017-07-14Labeling · Supplement 44 · standard — Letter ↗AP
2012-05-10Labeling · Supplement 42AP
2011-01-26Labeling · Supplement 40AP
2009-05-04Labeling · Supplement 39AP
2007-03-28Labeling · Supplement 38AP
2002-09-20Manufacturing (CMC) · Supplement 33AP
2002-05-23Manufacturing (CMC) · Supplement 32AP
2002-04-29Manufacturing (CMC) · Supplement 30AP
2002-04-29Manufacturing (CMC) · Supplement 29AP
2002-04-29Manufacturing (CMC) · Supplement 31AP
2001-08-30Manufacturing (CMC) · Supplement 28AP
2001-08-30Manufacturing (CMC) · Supplement 27AP
1998-09-10Manufacturing (CMC) · Supplement 26AP
1997-04-22Labeling · Supplement 25AP
1996-08-28Manufacturing (CMC) · Supplement 24AP
1994-06-23Labeling · Supplement 23AP
1992-08-28Labeling · Supplement 22AP
1991-08-05Manufacturing (CMC) · Supplement 21AP
1991-08-05Manufacturing (CMC) · Supplement 20AP
1991-03-28Manufacturing (CMC) · Supplement 18AP
1990-12-04Labeling · Supplement 19AP
1990-02-23Manufacturing (CMC) · Supplement 16AP
1989-12-28Labeling · Supplement 17AP
1989-05-01Labeling · Supplement 13AP
1988-11-14Manufacturing (CMC) · Supplement 14AP
1988-11-14Manufacturing (CMC) · Supplement 15AP
1988-03-29Manufacturing (CMC) · Supplement 11AP
1988-03-14Manufacturing (CMC) · Supplement 7AP
1988-02-03Manufacturing (CMC) · Supplement 9AP
1988-02-03Manufacturing (CMC) · Supplement 10AP
1988-02-03Manufacturing (CMC) · Supplement 8AP
1987-10-09Manufacturing (CMC) · Supplement 5AP
1986-01-14Manufacturing (CMC) · Supplement 2AP
1984-10-01Manufacturing (CMC) · Supplement 1AP
1983-11-10OriginalAP
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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