APPLICATION
ANDA070434
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-22
LATEST ACTION
2020-11-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FUROSEMIDEPrescription
FUROSEMIDE 10MG/ML · SOLUTION · ORAL
Approval history
2020-11-05Labeling · Supplement 36 · standardAP
2020-11-05Labeling · Supplement 40 · standardAP
2020-11-05Manufacturing (CMC) · Supplement 39 · unknownAP
2011-01-26Labeling · Supplement 31AP
2009-05-04Labeling · Supplement 30AP
2007-03-28Labeling · Supplement 29AP
2002-05-23Manufacturing (CMC) · Supplement 25AP
2000-11-30Manufacturing (CMC) · Supplement 24AP
2000-11-30Manufacturing (CMC) · Supplement 23AP
2000-09-22Manufacturing (CMC) · Supplement 21AP
2000-09-22Manufacturing (CMC) · Supplement 22AP
1997-04-21Manufacturing (CMC) · Supplement 18AP
1997-04-21Manufacturing (CMC) · Supplement 16AP
1997-04-21Labeling · Supplement 19AP
1997-04-21Manufacturing (CMC) · Supplement 17AP
1997-04-21Manufacturing (CMC) · Supplement 15AP
1996-08-28Manufacturing (CMC) · Supplement 20AP
1994-06-24Labeling · Supplement 14AP
1992-08-28Labeling · Supplement 13AP
1992-02-14Manufacturing (CMC) · Supplement 12AP
1990-12-04Labeling · Supplement 11AP
1989-12-28Labeling · Supplement 10AP
1989-05-26Labeling · Supplement 5AP
1989-05-26Labeling · Supplement 43AP
1988-10-21Manufacturing (CMC) · Supplement 7AP
1988-10-21Manufacturing (CMC) · Supplement 6AP
1988-07-12Manufacturing (CMC) · Supplement 3AP
1988-07-12Manufacturing (CMC) · Supplement 1AP
1988-07-12Manufacturing (CMC) · Supplement 4AP
1988-07-12Labeling · Supplement 2AP
1987-04-22OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.