Lisinopril

Treats hypertension. ANDA 77321, held by Lupin. Lisinopril.

As of Nov 14, 2026, ANDA 77321 (Lisinopril), held by Lupin, was first approved by FDA on Sep 9, 2005, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 9, 2005
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lisinopril tablet USP 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 tablet USP is 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
Sep 9, 2005	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


Apr 27, 2020	Supplement 41Labeling · Standard review	Approved	None posted
Apr 27, 2020	Supplement 38Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 35Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 31Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 27Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Apr 9, 2015	Supplement 24Labeling	Approved	None posted
Feb 4, 2011	Supplement 17Labeling	Approved	None posted
Nov 18, 2009	Supplement 12Labeling	Approved	None posted
May 29, 2009	Supplement 15Labeling	Approved	None posted
Jan 30, 2007	Supplement 2Labeling	Approved	None posted
Aug 8, 2006	Supplement 4Labeling	Approved	None posted
Sep 9, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77321
Drugs@FDA: Overview at FDA
Company: Lupin

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