Lisinopril

Treats hypertension. ANDA 203508, held by Invagen Pharms. Lisinopril.

As of Nov 14, 2026, ANDA 203508 (Lisinopril), held by Invagen Pharms, was first approved by FDA on Oct 29, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2013
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Oct 29, 2013	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 6 submissions, including labeling and manufacturing supplements


Sep 17, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Sep 17, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jun 2, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jun 2, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 29, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203508
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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