APPLICATION
ANDA077606
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-14
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 27 · standardAP
2020-07-16Labeling · Supplement 22 · standardAP
2020-07-16Labeling · Supplement 23 · standardAP
2015-11-18Labeling · Supplement 19 · standardAP
2015-11-18Labeling · Supplement 18 · standardAP
2014-02-26Labeling · Supplement 14 · standardAP
2014-02-26Labeling · Supplement 12 · standardAP
2014-02-26Labeling · Supplement 17 · standardAP
2014-02-26Labeling · Supplement 15 · standardAP
2014-02-26Labeling · Supplement 13 · standardAP
2014-02-26Labeling · Supplement 11AP
2014-02-26Labeling · Supplement 9AP
2011-01-18Labeling · Supplement 6AP
2007-02-06Labeling · Supplement 1AP
2006-03-14OriginalAP
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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