APPLICATION
ANDA205888
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-16
LATEST ACTION
2022-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRASUGRELPrescription
PRASUGREL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
PRASUGRELPrescription
PRASUGREL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2022-02-14Labeling · Supplement 6 · standardAP
2020-07-20Labeling · Supplement 3 · standardAP
2019-11-04Labeling · Supplement 2 · standardAP
2019-11-04Labeling · Supplement 1 · 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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