Lisinopril

ANDA 202554, held by Accord Hlthcare. Lisinopril.

As of Nov 14, 2026, ANDA 202554 (Lisinopril), held by Accord Hlthcare, was first approved by FDA on Jul 30, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2013
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 30, 2013	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
Lisinopril30MG · tablet;oral	Lisinopril	Discontinued
Lisinopril40MG · tablet;oral	Lisinopril	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 13, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jul 30, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202554
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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