APPLICATION
ANDA205897
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-16
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRASUGRELPrescription
PRASUGREL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
PRASUGRELPrescription
PRASUGREL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2025-04-25Labeling · Supplement 8 · standardAP
2024-04-17Labeling · Supplement 2 · standardAP
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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