APPLICATION
ANDA076674
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-05
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 20 · standardAP
2020-07-16Labeling · Supplement 19 · standardAP
2015-11-18Labeling · Supplement 17 · standardAP
2015-11-18Labeling · Supplement 16 · standardAP
2015-11-18Labeling · Supplement 14 · standardAP
2014-02-26Labeling · Supplement 13 · standardAP
2014-02-26Labeling · Supplement 12 · standardAP
2010-02-19Labeling · Supplement 11AP
2006-06-08Labeling · Supplement 5AP
2006-01-31Labeling · Supplement 2AP
2004-10-05OriginalAP
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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