APPLICATION
ANDA075459
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2020-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 10MG · TABLET · ORAL
Approval history
2020-04-14Labeling · Supplement 13 · standardAP
2020-04-14Labeling · Supplement 12 · standardAP
2016-02-18Labeling · Supplement 9 · standardAP
2015-08-17Manufacturing (CMC) · Supplement 8 · unknownAP
2015-08-17Labeling · Supplement 7AP
2002-10-01Labeling · Supplement 3AP
2002-04-24Labeling · Supplement 2AP
2001-09-10Manufacturing (CMC) · 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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