APPLICATION
ANDA074332
TYPE
ANDA
ORIGINAL APPROVAL
1994-10-31
LATEST ACTION
2020-07-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUMETANIDEDiscontinued
BUMETANIDE 0.25MG/ML · INJECTABLE · INJECTION
Approval history
2020-07-01Labeling · Supplement 15 · standardAP
2005-01-27Labeling · Supplement 8AP
2001-02-14Manufacturing (CMC) · Supplement 5AP
1998-06-01Labeling · Supplement 4AP
1997-07-09Manufacturing (CMC) · Supplement 2AP
1997-07-09Labeling · Supplement 3AP
1996-08-15Manufacturing (CMC) · Supplement 1AP
1994-10-31OriginalAP
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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