APPLICATION
NDA017820
TYPE
NDA
ORIGINAL APPROVAL
1978-07-18
LATEST ACTION
2002-07-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOBUTREX · ReferenceDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-01-08Manufacturing (CMC) · Supplement 34 · priorityAP
1996-03-06Labeling · Supplement 33 · priorityAP
1996-01-11Manufacturing (CMC) · Supplement 31 · priorityAP
1995-11-09Manufacturing (CMC) · Supplement 32 · priorityAP
1995-03-30Labeling · Supplement 29 · priorityAP
1995-03-10Manufacturing (CMC) · Supplement 30 · priorityAP
1994-04-20Labeling · Supplement 27 · priorityAP
1993-02-09Manufacturing (CMC) · Supplement 26 · priorityAP
1993-02-01Manufacturing (CMC) · Supplement 25 · priorityAP
1991-04-26Labeling · Supplement 23 · priorityAP
1990-12-20Labeling · Supplement 24 · priorityAP
1989-12-07Labeling · Supplement 22 · priorityAP
1989-06-23Labeling · Supplement 20 · priorityAP
1989-04-18Labeling · Supplement 21 · priorityAP
1988-04-21Labeling · Supplement 19 · priorityAP
1987-05-27Labeling · Supplement 18 · priorityAP
1987-05-27Labeling · Supplement 16 · priorityAP
1987-01-21Manufacturing (CMC) · Supplement 17 · priorityAP
1987-01-21Labeling · Supplement 15 · priorityAP
1986-09-08Labeling · Supplement 6 · priorityAP
1986-03-07Manufacturing (CMC) · Supplement 13 · priorityAP
1986-03-07Manufacturing (CMC) · Supplement 11 · priorityAP
1985-07-25Manufacturing (CMC) · Supplement 10 · priorityAP
1983-06-24Manufacturing (CMC) · Supplement 8 · priorityAP
1982-02-24Manufacturing (CMC) · Supplement 7 · priorityAP
1981-06-17Manufacturing (CMC) · Supplement 5 · priorityAP
1981-02-03Manufacturing (CMC) · Supplement 4 · priorityAP
1980-08-13Manufacturing (CMC) · Supplement 3 · priorityAP
1978-09-12Manufacturing (CMC) · Supplement 2 · priorityAP
1978-09-12Labeling · Supplement 1 · priorityAP
1978-07-18Type 1 - New Molecular Entity · Original · priorityAP
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.