APPLICATION
NDA018398
TYPE
NDA
ORIGINAL APPROVAL
1981-07-06
LATEST ACTION
1998-08-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOPAMINE HYDROCHLORIDEDiscontinued
DOPAMINE HYDROCHLORIDE 80MG/ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDEDiscontinued
DOPAMINE HYDROCHLORIDE 40MG/ML · INJECTABLE · INJECTION
Approval history
1998-08-04Manufacturing (CMC) · Supplement 24AP
1998-02-27Labeling · Supplement 23AP
1997-10-17Manufacturing (CMC) · Supplement 22AP
1996-07-30Labeling · Supplement 21AP
1991-07-29Labeling · Supplement 19AP
1987-04-28Manufacturing (CMC) · Supplement 16AP
1987-04-28Manufacturing (CMC) · Supplement 14AP
1985-06-17Manufacturing (CMC) · Supplement 11AP
1981-07-06OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.