APPLICATION
ANDA074292
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-16
LATEST ACTION
2001-02-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2001-02-14Manufacturing (CMC) · Supplement 8AP
1997-06-23Labeling · Supplement 7AP
1997-01-28Manufacturing (CMC) · Supplement 5AP
1997-01-28Manufacturing (CMC) · Supplement 4AP
1996-12-24Labeling · Supplement 6AP
1996-06-07Labeling · Supplement 2AP
1996-06-07Manufacturing (CMC) · Supplement 3AP
1996-06-07Manufacturing (CMC) · Supplement 1AP
1995-02-16OriginalAP
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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