Omeprazole

ANDA 75876, held by Strides Pharma. Omeprazole.

As of Nov 15, 2026, ANDA 75876 (Omeprazole), held by Strides Pharma, was first approved by FDA on May 29, 2003, with 22 approved supplements and 0 published complete response letters.

First approved: May 29, 2003
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
May 29, 2003	Original application	Approved	None posted

Products

3 strengths and forms


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

All 23 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 45Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 44Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 42Labeling · Standard review	Approved	None posted
Jun 7, 2018	Supplement 41Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 40Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 39Labeling · Standard review	Approved	None posted
Mar 20, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Mar 20, 2015	Supplement 36Labeling · Standard review	Approved	None posted
Mar 20, 2015	Supplement 33Labeling · Standard review	Approved	None posted
Sep 3, 2014	Supplement 32Manufacturing	Approved	None posted
Aug 9, 2012	Supplement 30Labeling	Approved	None posted
Aug 9, 2012	Supplement 27Labeling	Approved	None posted
Aug 9, 2012	Supplement 26Labeling	Approved	None posted
Jun 14, 2012	Supplement 28Manufacturing	Approved	None posted
Nov 23, 2010	Supplement 25Labeling	Approved	None posted
Jan 21, 2009	Supplement 8Labeling	Approved	None posted
Jul 31, 2008	Supplement 18Labeling	Approved	None posted
Mar 21, 2007	Supplement 15Labeling	Approved	None posted
Sep 26, 2006	Supplement 14Labeling	Approved	None posted
Nov 21, 2005	Supplement 9Labeling	Approved	None posted
Jun 1, 2004	Supplement 7Labeling	Approved	None posted
Mar 19, 2004	Supplement 6Labeling	Approved	None posted
May 29, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75876
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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