APPLICATION
ANDA078686
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-13
LATEST ACTION
2024-07-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ADENOSINEPrescription
ADENOSINE 3MG/ML · INJECTABLE · INJECTION
Approval history
2024-07-03Labeling · Supplement 13 · standardAP
2011-01-13Manufacturing (CMC) · Supplement 1AP
2010-02-04Labeling · Supplement 2AP
2009-05-13OriginalAP
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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