Lisinopril

As of Nov 14, 2026, ANDA 75999 (Lisinopril), held by Rising, was first approved by FDA on Jul 1, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2002
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 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 8 submissions, including labeling and manufacturing supplements


Sep 8, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Sep 8, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Feb 20, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Mar 25, 2003	Supplement 4Labeling	Approved	None posted
Jan 17, 2003	Supplement 1Labeling	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75999
Drugs@FDA: Overview at FDA
Company: Rising 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