APPLICATION
ANDA040733
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-13
LATEST ACTION
2021-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 75MG · TABLET · ORAL
DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 25MG · TABLET · ORAL
DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 50MG · TABLET · ORAL
Approval history
2021-02-02Labeling · Supplement 6 · standardAP
2016-11-30Manufacturing (CMC) · Supplement 4AP
2007-02-13OriginalAP
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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