Omeprazole

ANDA 205070, held by Pharmazone. Omeprazole.

As of Nov 15, 2026, ANDA 205070 (Omeprazole), held by Pharmazone, was first approved by FDA on Jun 29, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2018
Review: Standard
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 29, 2018	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 4 submissions, including labeling and manufacturing supplements


Jul 18, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Nov 27, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jun 29, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 205070
Drugs@FDA: Overview at FDA
Company: Pharmazone

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