FDA ANDA · ANDA070433
FUROSEMIDE
Sponsor: HIKMA
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APPLICATION
ANDA070433
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-22
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FUROSEMIDEPrescription
FUROSEMIDE 40MG/5ML · SOLUTION · ORAL
Approval history
2026-10-16Manufacturing (CMC) · Supplement 38 · unknownAP
2020-11-05Labeling · Supplement 35 · standardAP
2020-11-05Labeling · Supplement 32 · standardAP
2012-05-11Labeling · Supplement 29AP
2011-01-26Labeling · Supplement 28AP
2009-05-04Labeling · Supplement 27AP
2007-03-28Labeling · Supplement 26AP
2002-05-23Manufacturing (CMC) · Supplement 22AP
2000-09-22Manufacturing (CMC) · Supplement 20AP
2000-09-22Manufacturing (CMC) · Supplement 21AP
1998-10-08Manufacturing (CMC) · Supplement 19AP
1997-04-21Manufacturing (CMC) · Supplement 14AP
1997-04-21Manufacturing (CMC) · Supplement 12AP
1997-04-21Labeling · Supplement 15AP
1997-04-21Manufacturing (CMC) · Supplement 13AP
1997-04-21Manufacturing (CMC) · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 16AP
1994-06-24Labeling · Supplement 10AP
1992-08-28Labeling · Supplement 9AP
1990-12-18Labeling · Supplement 8AP
1989-12-28Labeling · Supplement 7AP
1989-04-19Labeling · Supplement 2AP
1988-11-07Manufacturing (CMC) · Supplement 5AP
1988-11-07Manufacturing (CMC) · Supplement 4AP
1988-07-13Manufacturing (CMC) · Supplement 1AP
1987-04-22OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →