APPLICATION
ANDA076194
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2020-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
Approval history
2020-07-07Labeling · Supplement 37 · standardAP
2020-07-07Labeling · Supplement 35 · standardAP
2020-07-07Labeling · Supplement 38 · standardAP
2014-02-26Labeling · Supplement 34 · standardAP
2013-09-10Labeling · Supplement 33 · standardAP
2013-09-10Labeling · Supplement 31 · standardAP
2013-09-10Labeling · Supplement 32 · standardAP
2008-07-31Labeling · Supplement 16AP
2008-01-29Labeling · Supplement 13AP
2007-01-10Labeling · Supplement 10AP
2004-08-17Labeling · Supplement 5AP
2002-07-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.