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FDA ANDA · ANDA206392

ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA206392
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-08
LATEST ACTION
2025-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ASPIRIN AND DIPYRIDAMOLEPrescription
ASPIRIN 25MG, DIPYRIDAMOLE 200MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-07-29Labeling · Supplement 24 · standardAP
2025-07-29Labeling · Supplement 12 · standardAP
2025-07-29Labeling · Supplement 19 · standardAP
2016-03-08UNKNOWN · Original · standardAP
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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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