Lisinopril

ANDA 75752, held by Heritage Pharma. Lisinopril.

As of Nov 14, 2026, ANDA 75752 (Lisinopril), held by Heritage Pharma, was first approved by FDA on Jul 1, 2002, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 1, 2002	Original application	Approved	Letter

Products

6 strengths and forms


Lisinopril2.5MG · tablet;oral	Lisinopril	Discontinued
Lisinopril5MG · tablet;oral	Lisinopril	Discontinued
Lisinopril10MG · tablet;oral	Lisinopril	Discontinued
Lisinopril20MG · tablet;oral	Lisinopril	Discontinued
Lisinopril30MG · tablet;oral	Lisinopril	Discontinued
Lisinopril40MG · tablet;oral	Lisinopril	Discontinued

All 17 submissions, including labeling and manufacturing supplements


May 30, 2024	Supplement 41Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 36Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 39Labeling · Standard review	Approved	None posted
Aug 1, 2013	Supplement 28Labeling	Approved	None posted
Aug 1, 2013	Supplement 30Labeling · Standard review	Approved	None posted
Aug 1, 2013	Supplement 32Labeling · Standard review	Approved	None posted
Aug 1, 2013	Supplement 35Labeling · Standard review	Approved	None posted
Dec 9, 2010	Supplement 23Manufacturing	Approved	None posted
Feb 22, 2010	Supplement 22Labeling	Approved	None posted
Apr 29, 2008	Supplement 13Labeling	Approved	None posted
Nov 5, 2007	Supplement 12Labeling	Approved	None posted
Feb 17, 2006	Supplement 7Labeling	Approved	None posted
Jun 29, 2005	Supplement 5Labeling	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75752
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