APPLICATION
NDA020059
TYPE
NDA
ORIGINAL APPROVAL
1995-05-18
LATEST ACTION
2014-08-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ADENOSCAN · ReferenceDiscontinued
ADENOSINE 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
ADENOSCAN · ReferenceDiscontinued
ADENOSINE 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
Approval history
2013-12-09Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-01Manufacturing (CMC) · Supplement 8 · standardAP
1999-10-26Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-10Labeling · Supplement 4 · standardAP
1997-01-07Manufacturing (CMC) · Supplement 3 · standardAP
1996-10-02Manufacturing (CMC) · Supplement 2 · standardAP
1995-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1995-05-18Type 6 - New Indication (no longer used) · Original · standard — Other Important Information from FDA ↗AP
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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