APPLICATION
NDA018226
TYPE
NDA
ORIGINAL APPROVAL
1983-02-28
LATEST ACTION
2002-10-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUMEX · ReferenceDiscontinued
BUMETANIDE 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-02-24Manufacturing (CMC) · Supplement 23 · standardAP
1999-01-06Manufacturing (CMC) · Supplement 22 · standardAP
1998-02-10Labeling · Supplement 19 · standardAP
1997-04-18Manufacturing (CMC) · Supplement 20 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 21 · standardAP
1993-10-21Labeling · Supplement 18 · standardAP
1993-06-11Manufacturing (CMC) · Supplement 17 · standardAP
1992-07-01Manufacturing (CMC) · Supplement 16 · standardAP
1991-03-01Labeling · Supplement 15AP
1989-01-05Labeling · Supplement 11AP
1988-10-14Manufacturing (CMC) · Supplement 14 · standardAP
1987-12-10Manufacturing (CMC) · Supplement 13 · standardAP
1987-12-10Manufacturing (CMC) · Supplement 12 · standardAP
1985-09-06Labeling · Supplement 7AP
1985-08-08Manufacturing (CMC) · Supplement 6 · standardAP
1985-07-03Manufacturing (CMC) · Supplement 4 · standardAP
1985-07-03Manufacturing (CMC) · Supplement 5 · standardAP
1984-12-14Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-01Efficacy · Supplement 2AP
1983-11-22Manufacturing (CMC) · Supplement 1 · standardAP
1983-02-28Type 3 - New Dosage Form · 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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