Omeprazole

ANDA 204661, held by Teva Pharms USA. Omeprazole.

As of Nov 15, 2026, ANDA 204661 (Omeprazole), held by Teva Pharms USA, was first approved by FDA on Jun 13, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2017
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 13, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Omeprazole20MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole40MG · capsule, delayed rel pellets;oral	Omeprazole	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Jun 13, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204661
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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