APPLICATION
NDA018826
TYPE
NDA
ORIGINAL APPROVAL
1983-09-30
LATEST ACTION
2025-06-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DOPAMINE HYDROCHLORIDE 160MG/100ML · INJECTABLE · INJECTION
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
Approval history
2013-12-16Manufacturing (CMC) · Supplement 44 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 28 · standardAP
1999-06-05Labeling · Supplement 26 · standardAP
1998-11-16Manufacturing (CMC) · Supplement 25 · standardAP
1998-04-08Labeling · Supplement 23 · standardAP
1997-09-07Manufacturing (CMC) · Supplement 24 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 20 · standardAP
1995-08-17Manufacturing (CMC) · Supplement 19 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 22 · standardAP
1995-04-14Labeling · Supplement 21 · standardAP
1994-07-07Labeling · Supplement 18 · standardAP
1994-06-14Manufacturing (CMC) · Supplement 17 · standardAP
1992-05-07Labeling · Supplement 16AP
1991-12-31Manufacturing (CMC) · Supplement 15 · standardAP
1991-07-18Manufacturing (CMC) · Supplement 14 · standardAP
1990-11-15Manufacturing (CMC) · Supplement 13 · standardAP
1990-07-25Manufacturing (CMC) · Supplement 11 · standardAP
1987-08-13Labeling · Supplement 10AP
1986-10-29Manufacturing (CMC) · Supplement 9 · standardAP
1986-09-24Manufacturing (CMC) · Supplement 8 · standardAP
1986-04-01Manufacturing (CMC) · Supplement 7 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 5 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 6 · standardAP
1984-06-27Manufacturing (CMC) · Supplement 2 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 3 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 1 · standardAP
1983-09-30Type 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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