Lisinopril

Treats hypertension. ANDA 76102, held by Heritage. Lisinopril.

As of Nov 14, 2026, ANDA 76102 (Lisinopril), held by Heritage, was first approved by FDA on Sep 30, 2002, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 30, 2002
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1.-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 offatal 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 pharmacologicclasses.

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
Sep 30, 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


Apr 29, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jul 13, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Jul 13, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jul 13, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Jul 13, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Jul 13, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Aug 16, 2013	Supplement 10Labeling · Standard review	Approved	None posted
Aug 22, 2008	Supplement 6Labeling	Approved	None posted
Jun 8, 2006	Supplement 5Labeling	Approved	None posted
Sep 30, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76102
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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