APPLICATION
ANDA075483
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2015-09-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 10MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 5MG · TABLET · ORAL
Approval history
2015-09-01Labeling · Supplement 15 · standardAP
2015-09-01Labeling · Supplement 14AP
2008-08-14Labeling · Supplement 10AP
2004-09-23Labeling · 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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