Lisinopril

Treats hypertension. ANDA 76164, held by Prinston Inc. Lisinopril.

As of Nov 14, 2026, ANDA 76164 (Lisinopril), held by Prinston Inc, was first approved by FDA on Jul 1, 2002, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 6
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, USP, 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 7 submissions below

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

Products

6 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


May 28, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 26, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Feb 2, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Feb 2, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Dec 19, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Oct 31, 2014	Supplement 11Manufacturing	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 76164
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