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FDA ANDA · ANDA075788
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Sponsor: TARO PHARM INDS
APPLICATION
ANDA075788
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-18
LATEST ACTION
2022-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEPrescription
ENALAPRIL MALEATE 10MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEPrescription
ENALAPRIL MALEATE 5MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
Approval history
2022-05-27Labeling · Supplement 21 · standardAP
2020-04-14Labeling · Supplement 16 · standardAP
2016-05-24Labeling · Supplement 12 · standardAP
2016-05-24Labeling · Supplement 13 · standardAP
2015-02-13Manufacturing (CMC) · Supplement 9AP
2014-11-04Labeling · Supplement 7 · standardAP
2014-11-04Labeling · Supplement 8 · standardAP
2011-07-05Labeling · Supplement 5AP
2009-10-30Labeling · Supplement 4AP
2008-11-26Labeling · Supplement 3AP
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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