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FDA ANDA · ANDA210318

ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE

Sponsor: GLENMARK SPECLT

APPLICATION
ANDA210318
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-24
LATEST ACTION
2021-11-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2021-11-16Labeling · Supplement 3 · standardAP
2021-04-14Labeling · Supplement 1 · standardAP
2019-05-24UNKNOWN · 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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