APPLICATION
ANDA074521
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-18
LATEST ACTION
2026-06-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 5MG/ML · INJECTABLE · INJECTION
Approval history
2026-06-04Manufacturing (CMC) · Supplement 25 · standardAP
2001-01-11Manufacturing (CMC) · Supplement 8AP
1998-04-15Manufacturing (CMC) · Supplement 6AP
1997-09-05Labeling · Supplement 4AP
1997-09-05Manufacturing (CMC) · Supplement 5AP
1997-09-05Manufacturing (CMC) · Supplement 3AP
1997-04-29Manufacturing (CMC) · Supplement 2AP
1997-04-29Manufacturing (CMC) · Supplement 1AP
1996-10-18OriginalAP
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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