APPLICATION
ANDA205987
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-02
LATEST ACTION
2024-05-29
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
2024-05-29Labeling · Supplement 6 · standardAP
2023-04-12Labeling · Supplement 5 · standardAP
2019-11-04Labeling · Supplement 2 · standardAP
2019-11-04Labeling · Supplement 1 · standardAP
2018-02-02UNKNOWN · Original · 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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