APPLICATION
ANDA075048
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2002-07-30
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
2002-07-30Labeling · Supplement 5AP
2002-05-10Manufacturing (CMC) · Supplement 1AP
2002-04-19Manufacturing (CMC) · Supplement 3AP
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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