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FDA ANDA · ANDA076116
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA076116
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-19
LATEST ACTION
2025-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDiscontinued
ENALAPRIL MALEATE 5MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEDiscontinued
ENALAPRIL MALEATE 10MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2025-07-25Labeling · Supplement 12 · standardAP
2015-12-11Labeling · Supplement 8 · standardAP
2015-12-11Labeling · Supplement 10 · standardAP
2015-12-11Labeling · Supplement 9 · standardAP
2015-12-11Labeling · Supplement 11 · standardAP
2011-01-12Labeling · Supplement 7AP
2003-05-29Labeling · Supplement 3AP
2002-09-05Labeling · Supplement 2AP
2002-01-08Manufacturing (CMC) · Supplement 1AP
2001-09-19OriginalAP
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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