APPLICATION
NDA019099
TYPE
NDA
ORIGINAL APPROVAL
1986-10-15
LATEST ACTION
2013-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% · ReferenceDiscontinued
DOPAMINE HYDROCHLORIDE 320MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% · ReferenceDiscontinued
DOPAMINE HYDROCHLORIDE 80MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
DOPAMINE HYDROCHLORIDE 160MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
DOPAMINE HYDROCHLORIDE 40MG/100ML · INJECTABLE · INJECTION
Approval history
2013-03-19Manufacturing (CMC) · Supplement 12 · standardAP
2002-09-17Manufacturing (CMC) · Supplement 7 · standardAP
1997-06-11Labeling · Supplement 6 · standardAP
1996-02-07Labeling · Supplement 5 · standardAP
1990-10-04Labeling · Supplement 4AP
1988-01-20Labeling · Supplement 2AP
1987-01-15Labeling · Supplement 1AP
1986-10-15Type 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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