APPLICATION
ANDA078510
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-01
LATEST ACTION
2019-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EPLERENONEPrescription
EPLERENONE 25MG · TABLET · ORAL
EPLERENONEPrescription
EPLERENONE 50MG · TABLET · ORAL
Approval history
2019-04-02Labeling · Supplement 13 · standardAP
2019-04-02Labeling · Supplement 14 · standardAP
2015-09-16Labeling · Supplement 9 · standardAP
2014-10-14Manufacturing (CMC) · Supplement 11AP
2013-02-20Labeling · Supplement 6 · standardAP
2013-02-20Labeling · Supplement 4AP
2011-05-13Labeling · Supplement 2AP
2008-08-01OriginalAP
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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