APPLICATION
NDA018225
TYPE
NDA
ORIGINAL APPROVAL
1983-02-28
LATEST ACTION
2024-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUMEX · ReferencePrescription
BUMETANIDE 0.5MG · TABLET · ORAL
BUMEX · ReferencePrescription
BUMETANIDE 2MG · TABLET · ORAL
BUMEX · ReferencePrescription
BUMETANIDE 1MG · TABLET · ORAL
Approval history
2015-09-28Manufacturing (CMC) · Supplement 25 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 20 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 17 · standardAP
1999-01-06Manufacturing (CMC) · Supplement 16 · standardAP
1998-02-10Labeling · Supplement 13 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 15 · standardAP
1997-08-20Manufacturing (CMC) · Supplement 14 · standardAP
1994-08-12Manufacturing (CMC) · Supplement 12 · standardAP
1993-10-21Labeling · Supplement 11 · standardAP
1991-06-11Manufacturing (CMC) · Supplement 9 · standardAP
1991-03-01Labeling · Supplement 10AP
1989-08-28Manufacturing (CMC) · Supplement 8 · standardAP
1989-01-05Labeling · Supplement 6AP
1987-12-10Manufacturing (CMC) · Supplement 7 · standardAP
1985-12-18Manufacturing (CMC) · Supplement 4 · standardAP
1985-09-06Labeling · Supplement 5AP
1985-06-14Efficacy · Supplement 2AP
1984-02-09Manufacturing (CMC) · Supplement 3 · standardAP
1983-11-29Manufacturing (CMC) · Supplement 1 · standardAP
1983-02-28Type 1 - New Molecular Entity · 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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