Lisinopril

ANDA 75944, held by Sun Pharm Inds Ltd. Lisinopril.

As of Nov 14, 2026, ANDA 75944 (Lisinopril), held by Sun Pharm Inds Ltd, 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	Rx
Lisinopril5MG · tablet;oral	Lisinopril	Rx
Lisinopril10MG · tablet;oral	Lisinopril	Rx
Lisinopril20MG · tablet;oral	Lisinopril	Rx
Lisinopril40MG · tablet;oral	Lisinopril	Rx
Lisinopril30MG · tablet;oral	Lisinopril	Rx

All 17 submissions, including labeling and manufacturing supplements


Apr 27, 2020	Supplement 29Labeling · Standard review	Approved	None posted
Sep 16, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Nov 25, 2015	Supplement 27Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 26Labeling · Standard review	Approved	None posted
Aug 5, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Aug 5, 2013	Supplement 21Labeling · Standard review	Approved	None posted
Aug 5, 2013	Supplement 22Labeling · Standard review	Approved	None posted
Aug 5, 2013	Supplement 23Labeling · Standard review	Approved	None posted
Mar 12, 2010	Supplement 19Labeling	Approved	None posted
Mar 8, 2010	Supplement 18Labeling	Approved	None posted
Feb 22, 2010	Supplement 17Labeling	Approved	None posted
Sep 24, 2007	Supplement 12Labeling	Approved	None posted
Feb 11, 2003	Supplement 1Manufacturing	Approved	None posted
Feb 11, 2003	Supplement 2Labeling	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75944
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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