APPLICATION
ANDA203896
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-02
LATEST ACTION
2021-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EPLERENONEDiscontinued
EPLERENONE 50MG · TABLET · ORAL
EPLERENONEDiscontinued
EPLERENONE 25MG · TABLET · ORAL
Approval history
2021-03-25Labeling · Supplement 3 · standardAP
2019-04-11Labeling · Supplement 2 · standardAP
2017-02-02UNKNOWN · OriginalAP
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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