APPLICATION
NDA018569
TYPE
NDA
ORIGINAL APPROVAL
1981-10-19
LATEST ACTION
2026-06-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FUROSEMIDEPrescription
FUROSEMIDE 40MG · TABLET · ORAL
FUROSEMIDEPrescription
FUROSEMIDE 20MG · TABLET · ORAL
FUROSEMIDEPrescription
FUROSEMIDE 80MG · TABLET · ORAL
Approval history
2015-06-05Manufacturing (CMC) · Supplement 62 · standardAP
2012-10-04Labeling · Supplement 61 · standardAP
2007-11-28Labeling · Supplement 58AP
2002-12-16Manufacturing (CMC) · Supplement 52 · standardAP
2002-04-19Manufacturing (CMC) · Supplement 51 · standardAP
2001-06-14Manufacturing (CMC) · Supplement 49 · standardAP
2001-06-14Manufacturing (CMC) · Supplement 50 · standardAP
2000-11-20Manufacturing (CMC) · Supplement 48 · standardAP
2000-02-03Manufacturing (CMC) · Supplement 47 · standardAP
1999-05-05Manufacturing (CMC) · Supplement 45 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 44 · standardAP
1996-11-08Manufacturing (CMC) · Supplement 43 · standardAP
1995-02-08Manufacturing (CMC) · Supplement 42 · standardAP
1994-04-13Manufacturing (CMC) · Supplement 41 · standardAP
1993-03-30Labeling · Supplement 40AP
1992-07-24Labeling · Supplement 39AP
1989-10-19Labeling · Supplement 38AP
1989-05-17Labeling · Supplement 37AP
1988-12-06Manufacturing (CMC) · Supplement 33 · standardAP
1988-12-06Manufacturing (CMC) · Supplement 34 · standardAP
1988-12-06Manufacturing (CMC) · Supplement 32 · standardAP
1988-08-25Labeling · Supplement 36AP
1987-11-17Manufacturing (CMC) · Supplement 29 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 27 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 25 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 28 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 24 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 30 · standardAP
1986-02-26Manufacturing (CMC) · Supplement 23 · standardAP
1985-02-27Manufacturing (CMC) · Supplement 21 · standardAP
1981-10-19Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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