APPLICATION
ANDA090072
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2024-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 4MG · TABLET · ORAL
PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 8MG · TABLET · ORAL
PERINDOPRIL ERBUMINEDiscontinued
PERINDOPRIL ERBUMINE 2MG · TABLET · ORAL
Approval history
2024-01-27Labeling · Supplement 10 · standardAP
2016-11-09Labeling · Supplement 8 · standardAP
2015-05-04Labeling · Supplement 4 · standardAP
2015-05-04Labeling · Supplement 2AP
2015-05-04Labeling · Supplement 7 · standardAP
2011-02-18Labeling · Supplement 1AP
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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