APPLICATION
ANDA074634
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-27
LATEST ACTION
2001-09-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 1.25GM BASE/100ML · INJECTABLE · INJECTION
Approval history
2001-09-07Manufacturing (CMC) · Supplement 3AP
1997-05-21Labeling · Supplement 2AP
1996-09-27OriginalAP
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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