APPLICATION
NDA020269
TYPE
NDA
ORIGINAL APPROVAL
1993-09-27
LATEST ACTION
1999-02-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%Discontinued
DOBUTAMINE HYDROCHLORIDE EQ 100MG BASE/100ML · INJECTABLE · INJECTION
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%Discontinued
DOBUTAMINE HYDROCHLORIDE EQ 200MG BASE/100ML · INJECTABLE · INJECTION
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%Discontinued
DOBUTAMINE HYDROCHLORIDE EQ 50MG BASE/100ML · INJECTABLE · INJECTION
Approval history
1999-02-17Labeling · Supplement 6 · standardAP
1996-07-17Manufacturing (CMC) · Supplement 4 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 5 · standardAP
1994-05-19Labeling · Supplement 1 · standardAP
1994-02-24Manufacturing (CMC) · Supplement 2 · standardAP
1993-09-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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