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FDA ANDA · ANDA076486
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Sponsor: MPP PHARMA
APPLICATION
ANDA076486
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-27
LATEST ACTION
2020-07-06
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
2020-07-06Labeling · Supplement 16 · standardAP
2015-10-06Labeling · Supplement 15 · standardAP
2015-10-06Labeling · Supplement 13 · standardAP
2015-10-06Labeling · Supplement 11 · standardAP
2009-04-29Labeling · Supplement 8AP
2007-02-06Labeling · Supplement 3AP
2004-10-27OriginalAP
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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