Omeprazole

ANDA 202384, held by Lupin. Omeprazole.

As of Nov 15, 2026, ANDA 202384 (Omeprazole), held by Lupin, was first approved by FDA on Aug 25, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 25, 2015
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 25, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Omeprazole40MG · capsule, delayed rel pellets;oral	Omeprazole	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 7, 2018	Supplement 2Labeling · Standard review	Approved	None posted
May 31, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Aug 25, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202384
Drugs@FDA: Overview at FDA
Company: Lupin

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