APPLICATION
ANDA078804
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-14
LATEST ACTION
2022-08-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ASPIRIN AND DIPYRIDAMOLEPrescription
ASPIRIN 25MG, DIPYRIDAMOLE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2022-08-05Labeling · Supplement 10 · standardAP
2020-02-27Labeling · Supplement 7 · standardAP
2020-02-27Labeling · Supplement 6 · standardAP
2018-05-02Manufacturing (CMC) · Supplement 2 · unknownAP
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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