APPLICATION
ANDA075479
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2021-08-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 5MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 10MG · TABLET · ORAL
ENALAPRIL MALEATEPrescription
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL
Approval history
2021-08-05Labeling · Supplement 36 · standardAP
2021-08-05Manufacturing (CMC) · Supplement 42 · unknownAP
2021-08-05Labeling · Supplement 40 · standardAP
2021-08-05Labeling · Supplement 37 · standardAP
2008-12-31Labeling · Supplement 30AP
2008-04-23Labeling · Supplement 28AP
2002-08-13Labeling · Supplement 4AP
2002-03-19Manufacturing (CMC) · Supplement 3AP
2001-08-30Manufacturing (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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