Lisinopril

Treats hypertension. ANDA 75743, held by Prinston. Lisinopril.

As of Nov 14, 2026, ANDA 75743 (Lisinopril), held by Prinston, was first approved by FDA on Jul 1, 2002, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older Adjunct therapy for heart failure Treatment of Acute Myocardial Infarction 1.1 Hypertension Lisinopril tablets are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 1, 2002	Original application	Approved	Letter

Products

6 strengths and forms


Lisinopril2.5MG · tablet;oral	Lisinopril	Rx
Lisinopril5MG · tablet;oral	Lisinopril	Rx
Lisinopril10MG · tablet;oral	Lisinopril	Rx
Lisinopril20MG · tablet;oral	Lisinopril	Rx
Lisinopril30MG · tablet;oral	Lisinopril	Rx
Lisinopril40MG · tablet;oral	Lisinopril	Rx

All 17 submissions, including labeling and manufacturing supplements


Apr 27, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Sep 8, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Feb 24, 2016	Supplement 13Manufacturing	Approved	None posted
Jan 4, 2016	Supplement 29Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 22Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 20Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 19Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 15Labeling	Approved	None posted
Dec 11, 2014	Supplement 14Labeling	Approved	None posted
Feb 25, 2008	Supplement 10Labeling	Approved	None posted
Jan 23, 2006	Supplement 9Labeling	Approved	None posted
Aug 30, 2005	Supplement 7Labeling	Approved	None posted
Oct 29, 2004	Supplement 6Labeling	Approved	None posted
Jun 9, 2004	Supplement 1Labeling	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75743
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters