← FDA DRUG APPROVALS

FDA ANDA · ANDA075999

LISINOPRIL

Sponsor: RISING

APPLICATION
ANDA075999
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2016-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LISINOPRILDiscontinued
LISINOPRIL 10MG · TABLET · ORAL
LISINOPRILDiscontinued
LISINOPRIL 2.5MG · TABLET · ORAL
LISINOPRILDiscontinued
LISINOPRIL 40MG · TABLET · ORAL
LISINOPRILDiscontinued
LISINOPRIL 20MG · TABLET · ORAL
LISINOPRILDiscontinued
LISINOPRIL 5MG · TABLET · ORAL
LISINOPRILDiscontinued
LISINOPRIL 30MG · TABLET · ORAL

Approval history

2016-09-08Labeling · Supplement 12 · standardAP
2016-09-08Labeling · Supplement 13 · standardAP
2015-04-13Labeling · Supplement 10 · standardAP
2015-04-13Labeling · Supplement 11 · standardAP
2013-02-20Labeling · Supplement 9 · standardAP
2003-03-25Labeling · Supplement 4AP
2003-01-17Labeling · Supplement 1AP
2002-07-01OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →