APPLICATION
NDA019937
TYPE
NDA
ORIGINAL APPROVAL
1989-10-30
LATEST ACTION
2013-12-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ADENOCARD · ReferenceDiscontinued
ADENOSINE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2013-12-13Manufacturing (CMC) · Supplement 28 · priorityAP
2011-02-23Labeling · Supplement 26 · unknownAP
2001-09-21Manufacturing (CMC) · Supplement 18 · priorityAP
2000-02-01Manufacturing (CMC) · Supplement 17 · priorityAP
1999-11-02Manufacturing (CMC) · Supplement 16 · priorityAP
1999-04-20Labeling · Supplement 15 · standardAP
1997-02-13Manufacturing (CMC) · Supplement 14 · priorityAP
1996-07-29Labeling · Supplement 13 · standardAP
1996-02-09Labeling · Supplement 11 · standardAP
1995-12-27Manufacturing (CMC) · Supplement 12 · priorityAP
1995-06-26Manufacturing (CMC) · Supplement 10 · priorityAP
1995-06-09Labeling · Supplement 9 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 3 · priorityAP
1993-10-27Manufacturing (CMC) · Supplement 8 · priorityAP
1992-06-11Labeling · Supplement 7AP
1990-11-15Manufacturing (CMC) · Supplement 5 · priorityAP
1990-09-13Labeling · Supplement 4AP
1990-05-10Labeling · Supplement 2AP
1989-12-04Manufacturing (CMC) · Supplement 1 · priorityAP
1989-10-30Type 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.