APPLICATION
ANDA074206
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-19
LATEST ACTION
1997-04-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
1997-04-01Labeling · Supplement 4AP
1997-03-03Labeling · Supplement 3AP
1995-06-02Manufacturing (CMC) · Supplement 2AP
1994-04-19Manufacturing (CMC) · Supplement 1AP
1993-10-19OriginalAP
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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