Lisinopril

Treats hypertension. ANDA 75903, held by Annora Pharma. Lisinopril.

As of Nov 14, 2026, ANDA 75903 (Lisinopril), held by Annora Pharma, was first approved by FDA on Jul 1, 2002, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lisinopril tablets are 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 10 submissions below

Date	Submission	Status	Documents
Jul 1, 2002	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 10 submissions, including labeling and manufacturing supplements


Dec 23, 2021	Supplement 23Manufacturing	Approved	None posted
Aug 17, 2021	Supplement 21Manufacturing	Approved	None posted
Apr 27, 2020	Supplement 20Labeling · Standard review	Approved	None posted
May 7, 2010	Supplement 19Labeling	Approved	None posted
Dec 1, 2009	Supplement 18Labeling	Approved	None posted
Dec 1, 2009	Supplement 17Labeling	Approved	None posted
Feb 13, 2007	Supplement 14Labeling	Approved	None posted
Jul 3, 2006	Supplement 15Labeling	Approved	None posted
Oct 25, 2002	Supplement 1Manufacturing	Approved	None posted
Jul 1, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75903
Drugs@FDA: Overview at FDA
Company: Annora 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