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FDA ANDA · ANDA075727
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Sponsor: COSETTE PHARMS NC
APPLICATION
ANDA075727
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-18
LATEST ACTION
2020-05-28
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
2020-05-28Labeling · Supplement 22 · standardAP
2014-11-03Labeling · Supplement 18AP
2014-11-03Labeling · Supplement 19 · standardAP
2011-05-02Labeling · Supplement 17AP
2008-12-31Labeling · Supplement 15AP
2008-07-24Labeling · Supplement 13AP
2003-06-27Labeling · Supplement 3AP
2002-08-28Labeling · 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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