Lisinopril

Treats hypertension. ANDA 77622, held by Aurobindo. Lisinopril.

As of Nov 14, 2026, ANDA 77622 (Lisinopril), held by Aurobindo, was first approved by FDA on Feb 22, 2006, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 22, 2006
Supplements approved: 12
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 13 submissions below

Date	Submission	Status	Documents
Feb 22, 2006	Original application	Approved	None posted

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 13 submissions, including labeling and manufacturing supplements


May 13, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Sep 13, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Apr 7, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Jun 13, 2014	Supplement 11Manufacturing	Approved	None posted
Aug 22, 2013	Supplement 18Labeling · Standard review	Approved	None posted
Aug 20, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Dec 4, 2009	Supplement 5Labeling	Approved	None posted
Jan 28, 2008	Supplement 2Labeling	Approved	None posted
Feb 6, 2007	Supplement 1Labeling	Approved	None posted
Feb 22, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77622
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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