← FDA DRUG APPROVALS

FDA NDA · NDA019558

PRINIVIL

Sponsor: MERCK

APPLICATION
NDA019558
TYPE
NDA
ORIGINAL APPROVAL
1987-12-29
LATEST ACTION
2021-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRINIVILDiscontinued
LISINOPRIL 2.5MG · TABLET · ORAL
PRINIVILDiscontinued
LISINOPRIL 40MG · TABLET · ORAL
PRINIVILDiscontinued
LISINOPRIL 10MG · TABLET · ORAL
PRINIVILDiscontinued
LISINOPRIL 20MG · TABLET · ORAL
PRINIVILDiscontinued
LISINOPRIL 5MG · TABLET · ORAL

Approval history

2021-11-09Labeling · Supplement 63 · standard — Label ↗AP
2018-10-12Labeling · Supplement 62 · standard — Label ↗AP
2017-09-19Labeling · Supplement 61 · standard — Label ↗AP
2016-10-14Labeling · Supplement 60 · standard — Letter ↗AP
2015-08-28Labeling · Supplement 59 · standard — Letter ↗AP
2015-07-08Labeling · Supplement 57 · standard — Label ↗AP
2014-08-22Manufacturing (CMC) · Supplement 58 · standardAP
2013-02-26Labeling · Supplement 56 · standard — Label ↗AP
2012-06-07Labeling · Supplement 55 · unknown — Label ↗AP
2011-11-17Labeling · Supplement 54 · unknown — Label ↗AP
2011-06-10Labeling · Supplement 53 · unknown — Letter ↗AP
2008-10-09Labeling · Supplement 52 · standard — Letter ↗AP
2008-10-09Labeling · Supplement 51 · standard — Letter ↗AP
2007-02-02Labeling · Supplement 50 · standard — Letter ↗AP
2006-10-18Labeling · Supplement 49 · standard — Letter ↗AP
2006-06-16Labeling · Supplement 47 · standard — Letter ↗AP
2005-10-05Labeling · Supplement 46 · standard — Letter ↗AP
2004-05-05Labeling · Supplement 40 · standard — Letter ↗AP
2004-03-02Labeling · Supplement 44 · standard — Letter ↗AP
2003-05-29Efficacy · Supplement 43 · standard — Label ↗AP
2001-08-23Manufacturing (CMC) · Supplement 42 · standardAP
2001-08-07Labeling · Supplement 38 · standardAP
2001-04-26Manufacturing (CMC) · Supplement 41 · standardAP
2000-06-09Manufacturing (CMC) · Supplement 39 · standardAP
1999-03-15Manufacturing (CMC) · Supplement 37 · standardAP
1999-02-17Labeling · Supplement 36 · standard — Review ↗AP
1996-09-03Labeling · Supplement 35 · standardAP
1996-09-03Labeling · Supplement 19 · standardAP
1995-11-24Efficacy · Supplement 27 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 34 · standardAP
1995-09-28Labeling · Supplement 33 · standardAP
1995-09-28Labeling · Supplement 31 · standardAP
1995-06-26Manufacturing (CMC) · Supplement 32 · standardAP
1995-06-08Manufacturing (CMC) · Supplement 30 · standardAP
1995-03-21Manufacturing (CMC) · Supplement 29 · standardAP
1995-02-22Labeling · Supplement 28 · standardAP
1994-07-24Labeling · Supplement 26 · standardAP
1994-05-11Labeling · Supplement 22 · standardAP
1994-03-10Labeling · Supplement 25 · standardAP
1994-01-28Manufacturing (CMC) · Supplement 23 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →