APPLICATION
ANDA074098
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-21
LATEST ACTION
2002-10-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2002-10-22Labeling · Supplement 7AP
1998-02-18Labeling · Supplement 3AP
1997-10-30Manufacturing (CMC) · Supplement 5AP
1997-09-22Manufacturing (CMC) · Supplement 4AP
1997-09-15Manufacturing (CMC) · Supplement 2AP
1996-12-10Labeling · Supplement 1AP
1995-02-21OriginalAP
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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