Omeprazole

ANDA 75785, held by Impax Labs. Omeprazole.

As of Nov 15, 2026, ANDA 75785 (Omeprazole), held by Impax Labs, was first approved by FDA on Oct 22, 2007, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2007
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 22, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Omeprazole10MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole20MG · capsule, delayed rel pellets;oral	Omeprazole	Rx
Omeprazole40MG · capsule, delayed rel pellets;oral	Omeprazole	Rx

All 9 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Jun 5, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Aug 21, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Aug 21, 2015	Supplement 5Labeling	Approved	None posted
Jan 21, 2009	Supplement 3Labeling	Approved	None posted
Oct 22, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 75785
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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