Prevacid 24 Hr

NDA 22327, held by Perrigo Pharma Intl. Lansoprazole.

As of Nov 15, 2026, NDA 22327 (Prevacid 24 Hr), held by Perrigo Pharma Intl, was first approved by FDA on May 18, 2009, with 18 approved supplements and 0 published complete response letters.

First approved: May 18, 2009
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 18, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prevacid 24 Hr15MG · capsule, delayed rel pellets;oral	Lansoprazole	OTCReference drug

All 19 submissions, including labeling and manufacturing supplements


Dec 29, 2022	Supplement 31Labeling · Standard review	Approved	Letter Label
Jun 23, 2022	Supplement 30Labeling · Standard review	Approved	Label Letter
Mar 1, 2022	Supplement 29Labeling · Standard review	Approved	Label Letter
Apr 9, 2019	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 28, 2017	Supplement 26Labeling · Standard review	Approved	Label Letter
Feb 24, 2017	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 30, 2015	Supplement 22Labeling · Standard review	Approved	Letter Label
Jun 12, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 19, 2012	Supplement 20Labeling · Standard review	Approved	Label Letter
Apr 23, 2012	Supplement 19Labeling · Standard review	Approved	Label Letter
Apr 5, 2012	Supplement 18Labeling · Standard review	Approved	Label Letter
Oct 31, 2011	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 27, 2011	Supplement 16Labeling · Standard review	Approved	Label Letter
Apr 19, 2011	Supplement 13Labeling	Approved	Label Letter
Jan 26, 2011	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 1, 2010	Supplement 8Labeling	Approved	Label Letter
Sep 15, 2010	Supplement 4Labeling	Approved	Letter
Apr 1, 2010	Supplement 3Manufacturing	Approved	None posted
May 18, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22327
Drugs@FDA: Overview at FDA
Company: Perrigo Pharma International

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