APPLICATION
ANDA075480
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2016-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 10MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 5MG · TABLET · ORAL
Approval history
2016-04-18Labeling · Supplement 14 · standardAP
2016-04-18Labeling · Supplement 15 · standardAP
2015-01-23Labeling · Supplement 13 · standardAP
2011-05-30Manufacturing (CMC) · Supplement 10AP
2002-12-19Labeling · 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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