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FDA NDA · NDA020255

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE

dobutamine hydrochloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020255
TYPE
NDA
ORIGINAL APPROVAL
1993-09-27
LATEST ACTION
2023-09-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOBUTAMINE HYDROCHLORIDE EQ 400MG BASE/100ML · INJECTABLE · INJECTION
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOBUTAMINE HYDROCHLORIDE EQ 100MG BASE/100ML · INJECTABLE · INJECTION
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOBUTAMINE HYDROCHLORIDE EQ 50MG BASE/100ML · INJECTABLE · INJECTION
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOBUTAMINE HYDROCHLORIDE EQ 200MG BASE/100ML · INJECTABLE · INJECTION

Approval history

2023-09-08Labeling · Supplement 25 · standard — Label ↗AP
2020-12-10Labeling · Supplement 22 · standard — Letter ↗AP
2019-03-27Labeling · Supplement 20 · standard — Letter ↗AP
2013-04-17Labeling · Supplement 16 · standard — Label ↗AP
2012-03-05Labeling · Supplement 14 · standard — Letter ↗AP
2003-07-24Labeling · Supplement 9 · standard — Letter ↗AP
2003-07-24Labeling · Supplement 11 · standard — Letter ↗AP
2001-05-31Labeling · Supplement 8 · standardAP
2000-06-14Labeling · Supplement 6 · standard — Review ↗AP
1999-11-23Manufacturing (CMC) · Supplement 7 · standardAP
1999-04-21Labeling · Supplement 5 · standardAP
1998-04-30Manufacturing (CMC) · Supplement 4 · standardAP
1996-03-08Manufacturing (CMC) · Supplement 3 · standardAP
1994-09-29Manufacturing (CMC) · Supplement 2 · standardAP
1994-02-16Manufacturing (CMC) · Supplement 1 · standardAP
1993-09-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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