APPLICATION
ANDA070086
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-24
LATEST ACTION
2020-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FUROSEMIDEPrescription
FUROSEMIDE 80MG · TABLET · ORAL
Approval history
2020-11-05Labeling · Supplement 40 · standardAP
2020-11-05Labeling · Supplement 43 · standardAP
2012-05-10Labeling · Supplement 38AP
2011-01-26Labeling · Supplement 36AP
2009-05-04Labeling · Supplement 35AP
2007-03-28Labeling · Supplement 34AP
2002-05-23Manufacturing (CMC) · Supplement 30AP
2002-05-07Manufacturing (CMC) · Supplement 28AP
2002-05-07Manufacturing (CMC) · Supplement 29AP
2002-05-07Manufacturing (CMC) · Supplement 27AP
2001-08-30Manufacturing (CMC) · Supplement 26AP
2001-08-30Manufacturing (CMC) · Supplement 25AP
1998-09-10Manufacturing (CMC) · Supplement 24AP
1997-04-22Labeling · Supplement 23AP
1996-08-28Manufacturing (CMC) · Supplement 22AP
1995-04-13Labeling · Supplement 21AP
1994-06-24Labeling · Supplement 20AP
1992-08-28Labeling · Supplement 19AP
1991-11-18Manufacturing (CMC) · Supplement 17AP
1991-05-03Manufacturing (CMC) · Supplement 16AP
1991-05-03Manufacturing (CMC) · Supplement 12AP
1991-03-13Manufacturing (CMC) · Supplement 2AP
1991-03-13Manufacturing (CMC) · Supplement 14AP
1991-03-13Labeling · Supplement 3AP
1990-12-18Labeling · Supplement 15AP
1989-12-28Labeling · Supplement 13AP
1989-04-19Labeling · Supplement 9AP
1988-09-13Manufacturing (CMC) · Supplement 11AP
1988-07-12Manufacturing (CMC) · Supplement 6AP
1988-05-06Labeling · Supplement 7AP
1986-01-24OriginalAP
1985-05-13Manufacturing (CMC) · Supplement 1AP
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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