Lisinopril

ANDA 78402, held by Wockhardt Bio AG. Lisinopril.

As of Nov 14, 2026, ANDA 78402 (Lisinopril), held by Wockhardt Bio AG, was first approved by FDA on Apr 19, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 19, 2007
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
Apr 19, 2007	Original application	Approved	None posted

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
Lisinopril30MG · tablet;oral	Lisinopril	Rx
Lisinopril40MG · tablet;oral	Lisinopril	Rx

All 6 submissions, including labeling and manufacturing supplements


May 13, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Jan 15, 2015	Supplement 5Labeling	Approved	None posted
Dec 22, 2014	Supplement 1Labeling	Approved	None posted
Apr 19, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78402
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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