APPLICATION
ANDA075657
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-23
LATEST ACTION
2019-08-07
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
2019-08-07Labeling · Supplement 17 · standardAP
2019-08-07Labeling · Supplement 15 · standardAP
2016-02-25Labeling · Supplement 13 · standardAP
2016-02-25Labeling · Supplement 14 · standardAP
2015-04-06Manufacturing (CMC) · Supplement 9AP
2014-11-03Labeling · Supplement 11 · standardAP
2010-01-28Labeling · Supplement 7AP
2008-07-24Labeling · Supplement 5AP
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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