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FDA NDA · NDA020201

DOBUTAMINE IN DEXTROSE

Sponsor: HOSPIRA

APPLICATION
NDA020201
TYPE
NDA
ORIGINAL APPROVAL
1993-09-27
LATEST ACTION
2025-11-25
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

2025-11-25Manufacturing (CMC) · Supplement 47 — Label ↗AP
2024-06-12Labeling · Supplement 45 · standard — Label ↗AP
2019-05-24Labeling · Supplement 40 · standard — Label ↗AP
2016-05-31Labeling · Supplement 36 · standard — Label ↗AP
2002-12-02Manufacturing (CMC) · Supplement 17 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 16 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 14 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 15 · standardAP
2001-04-10Labeling · Supplement 13 · standard — Letter ↗AP
1999-09-01Labeling · Supplement 12 · standardAP
1999-02-17Labeling · Supplement 9 · standardAP
1998-10-28Manufacturing (CMC) · Supplement 11 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 10 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 6 · standardAP
1995-08-17Manufacturing (CMC) · Supplement 5 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 8 · standardAP
1994-07-07Labeling · Supplement 4 · standardAP
1994-07-07Manufacturing (CMC) · Supplement 3 · standardAP
1994-05-19Labeling · Supplement 2 · standardAP
1994-02-24Manufacturing (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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