Lisinopril

ANDA 76063, held by Hikma. Lisinopril.

As of Nov 14, 2026, ANDA 76063 (Lisinopril), held by Hikma, was first approved by FDA on Jul 1, 2002, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 1, 2002	Original application	Approved	None posted

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
Lisinopril40MG · tablet;oral	Lisinopril	Discontinued
Lisinopril30MG · tablet;oral	Lisinopril	Discontinued

All 29 submissions, including labeling and manufacturing supplements


Apr 11, 2024	Supplement 67Labeling · Standard review	Approved	None posted
May 13, 2020	Supplement 65Labeling · Standard review	Approved	None posted
Sep 15, 2016	Supplement 64Labeling · Standard review	Approved	None posted
Sep 15, 2016	Supplement 63Labeling · Standard review	Approved	None posted
Sep 15, 2016	Supplement 61Labeling · Standard review	Approved	None posted
Sep 15, 2016	Supplement 60Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 57Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 56Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 55Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 54Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 53Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 51Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 48Labeling · Standard review	Approved	None posted
Aug 14, 2013	Supplement 49Labeling · Standard review	Approved	None posted
Aug 5, 2013	Supplement 40Manufacturing	Approved	None posted
Feb 28, 2013	Supplement 47Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 45Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 42Labeling	Approved	None posted
Feb 17, 2010	Supplement 38Labeling	Approved	None posted
Sep 10, 2009	Supplement 35Labeling	Approved	None posted
Aug 21, 2009	Supplement 31Labeling	Approved	None posted
Jan 28, 2008	Supplement 33Labeling	Approved	None posted
Jun 25, 2007	Supplement 29Labeling	Approved	None posted
Feb 16, 2007	Supplement 19Labeling	Approved	None posted
Mar 13, 2006	Supplement 13Labeling	Approved	None posted
Mar 13, 2006	Supplement 11Labeling	Approved	None posted
Jun 27, 2003	Supplement 3Labeling	Approved	None posted
Jun 27, 2003	Supplement 2Manufacturing	Approved	None posted
Jul 1, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76063
Drugs@FDA: Overview at FDA
Company: Hikma

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