APPLICATION
ANDA074086
TYPE
ANDA
ORIGINAL APPROVAL
1993-11-29
LATEST ACTION
2002-12-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOBUTAMINE HYDROCHLORIDEPrescription
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2002-12-31Manufacturing (CMC) · Supplement 8AP
1997-10-23Manufacturing (CMC) · Supplement 7AP
1997-04-07Labeling · Supplement 5AP
1996-12-02Labeling · Supplement 4AP
1996-10-03Manufacturing (CMC) · Supplement 3AP
1994-06-07Manufacturing (CMC) · Supplement 1AP
1993-11-29OriginalAP
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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