APPLICATION
ANDA205913
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-19
LATEST ACTION
2024-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRASUGRELDiscontinued
PRASUGREL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
PRASUGRELDiscontinued
PRASUGREL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2024-08-20Labeling · Supplement 13 · standardAP
2022-02-04Labeling · Supplement 8 · standardAP
2019-11-04Labeling · Supplement 1 · standardAP
2018-06-19UNKNOWN · 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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