APPLICATION
ANDA074613
TYPE
ANDA
ORIGINAL APPROVAL
1997-11-18
LATEST ACTION
2000-08-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUMETANIDEDiscontinued
BUMETANIDE 0.25MG/ML · INJECTABLE · INJECTION
Approval history
2000-08-09Labeling · Supplement 3AP
1999-09-20Manufacturing (CMC) · Supplement 1AP
1999-05-18Labeling · Supplement 2AP
1997-11-18OriginalAP
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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