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FDA NDA · NDA019615
DOPAMINE HYDROCHLORIDE AND DEXTROSE
dopamine hydrochloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA019615
TYPE
NDA
ORIGINAL APPROVAL
1987-03-27
LATEST ACTION
2020-12-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOPAMINE HYDROCHLORIDE 320MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOPAMINE HYDROCHLORIDE 80MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOPAMINE HYDROCHLORIDE 640MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOPAMINE HYDROCHLORIDE 160MG/100ML · INJECTABLE · INJECTION
Approval history
2013-05-21Manufacturing (CMC) · Supplement 22 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 15 · standardAP
1999-11-23Manufacturing (CMC) · Supplement 13 · standardAP
1998-03-27Labeling · Supplement 11 · standardAP
1996-02-07Labeling · Supplement 10 · standardAP
1995-08-30Labeling · Supplement 9 · standardAP
1994-09-29Manufacturing (CMC) · Supplement 8 · standardAP
1994-02-07Manufacturing (CMC) · Supplement 7 · standardAP
1991-12-02Manufacturing (CMC) · Supplement 5 · standardAP
1990-11-09Manufacturing (CMC) · Supplement 4 · standardAP
1989-12-07Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-28Manufacturing (CMC) · Supplement 2 · standardAP
1988-11-15Manufacturing (CMC) · Supplement 1 · standardAP
1987-03-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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