APPLICATION
ANDA076113
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2024-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
Approval history
2024-05-29Labeling · Supplement 39 · standardAP
2020-08-20Labeling · Supplement 38 · standardAP
2018-05-21Labeling · Supplement 29 · standardAP
2018-05-21Manufacturing (CMC) · Supplement 31 · unknownAP
2018-05-21Labeling · Supplement 36 · standardAP
2018-05-21Labeling · Supplement 34 · standardAP
2018-05-21Labeling · Supplement 30 · standardAP
2014-02-26Labeling · Supplement 26 · standardAP
2013-09-06Labeling · Supplement 25 · standardAP
2013-09-06Labeling · Supplement 24AP
2010-02-25Labeling · Supplement 19AP
2010-02-25Labeling · Supplement 23AP
2007-12-04Labeling · Supplement 10AP
2004-09-23Labeling · Supplement 4AP
2003-06-06Labeling · Supplement 2AP
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.