APPLICATION
ANDA074114
TYPE
ANDA
ORIGINAL APPROVAL
1993-11-30
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 5AP
1999-02-02Manufacturing (CMC) · Supplement 4AP
1998-08-28Manufacturing (CMC) · Supplement 3AP
1996-12-04Manufacturing (CMC) · Supplement 2AP
1996-07-31Labeling · Supplement 1AP
1993-11-30OriginalAP
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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