Lisinopril

ANDA 75783, held by Teva. Lisinopril.

As of Nov 14, 2026, ANDA 75783 (Lisinopril), held by Teva, 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


May 28, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jun 25, 2007	Supplement 17Labeling	Approved	None posted
Oct 29, 2002	Supplement 1Manufacturing	Approved	None posted
Oct 29, 2002	Supplement 2Manufacturing	Approved	None posted
Oct 29, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 29, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 29, 2002	Supplement 5Manufacturing	Approved	None posted
Jul 1, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75783
Drugs@FDA: Overview at FDA
Company: Teva 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