APPLICATION
ANDA074277
TYPE
ANDA
ORIGINAL APPROVAL
1994-10-31
LATEST ACTION
2024-03-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOBUTAMINE HYDROCHLORIDEPrescription
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-03-06Labeling · Supplement 21 · standardAP
2001-11-07Labeling · Supplement 13AP
2001-04-03Manufacturing (CMC) · Supplement 12AP
2001-03-05Manufacturing (CMC) · Supplement 11AP
1998-07-20Labeling · Supplement 10AP
1997-12-22Labeling · Supplement 9AP
1997-02-26Labeling · Supplement 3AP
1996-08-28Manufacturing (CMC) · Supplement 6AP
1996-08-28Manufacturing (CMC) · Supplement 7AP
1994-10-31OriginalAP
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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