APPLICATION
ANDA075178
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-23
LATEST ACTION
2018-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 10MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 5MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL
Approval history
2018-12-10Labeling · Supplement 14 · standardAP
2018-12-10Labeling · Supplement 15 · standardAP
2016-04-12Labeling · Supplement 13 · standardAP
2015-05-01Labeling · Supplement 10 · standardAP
2015-05-01Labeling · Supplement 5AP
2015-05-01Labeling · Supplement 11 · standardAP
2010-08-06Labeling · Supplement 9AP
2008-09-04Labeling · Supplement 8AP
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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