Prevacid

NDA 20406, held by Takeda Pharms USA. Lansoprazole.

As of Nov 13, 2026, NDA 20406 (Prevacid), held by Takeda Pharms USA, was first approved by FDA on May 10, 1995, with 72 approved supplements and 0 published complete response letters.

First approved: May 10, 1995
Review: Standard
Supplements approved: 72
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 73 submissions below


Oct 28, 2008	Supplement 67Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Jun 17, 2004	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 31, 2002	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 1, 2001	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 30, 2000	Supplement 33Efficacy (new indication or use)	Approved	Letter Label
Jul 6, 1999	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jul 20, 1998	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter
Mar 12, 1998	Supplement 16Efficacy (new indication or use)	Approved	Review
May 8, 1997	Supplement 11Efficacy (new indication or use)	Approved	None posted
Apr 17, 1997	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 8, 1996	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
May 10, 1995	Original applicationNew molecular entity · Standard review	Approved	Review Pediatric Written Request Pediatric Amendment 1 Pediatric Medical Review

Products

2 strengths and forms


Prevacid15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, delayed rel pellets;oral	Lansoprazole	DiscontinuedReference drug
Prevacid30MG · capsule, delayed rel pellets;oral	Lansoprazole	RxReference drug

All 73 submissions, including labeling and manufacturing supplements


Aug 8, 2023	Supplement 95Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 4, 2022	Supplement 94Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 92Labeling · Standard review	Approved	Letter Label
Sep 11, 2020	Supplement 90Labeling · Standard review	Approved	Label Letter
Jun 7, 2018	Supplement 87Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 88Labeling · Standard review	Approved	Letter Label
Apr 13, 2018	Supplement 84Labeling · Standard review	Approved	Label Letter
Oct 18, 2017	Supplement 83Labeling · Standard review	Approved	Label Letter
Oct 24, 2016	Supplement 82Labeling · Standard review	Approved	Label Letter
Dec 16, 2015	Supplement 80Labeling · Standard review	Approved	Letter Label
Dec 19, 2014	Supplement 81Labeling	Approved	Label Letter
Sep 28, 2012	Supplement 78Labeling · Standard review	Approved	Letter Label
May 3, 2012	Supplement 79Labeling · Standard review	Approved	Letter Label
Oct 28, 2011	Supplement 76Labeling · Standard review	Approved	Label Letter
Jun 1, 2011	Supplement 75Labeling · Standard review	Approved	Label Letter
May 20, 2011	Supplement 77Labeling	Approved	Label Letter
Sep 3, 2010	Supplement 74Labeling	Approved	Label Letter
May 12, 2010	Supplement 73Labeling	Approved	Letter Label
Jul 31, 2009	Supplement 71Labeling · Standard review	Approved	Letter Label
Oct 28, 2008	Supplement 67Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Written Request Pediatric Amendment 1
Sep 8, 2008	Supplement 68Manufacturing	Approved	None posted
Apr 21, 2008	Supplement 65Labeling · Standard review	Approved	Letter
Jun 14, 2007	Supplement 64Labeling · Standard review	Approved	Letter Label
Apr 12, 2006	Supplement 58Labeling · Standard review	Approved	Letter Label
Jun 17, 2004	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 15, 2004	Supplement 56Labeling · Standard review	Approved	Letter Label
Aug 5, 2003	Supplement 55Labeling · Standard review	Approved	Letter
Dec 3, 2002	Supplement 48Labeling · Standard review	Approved	Review Letter
Aug 30, 2002	Supplement 52Labeling · Standard review	Approved	Review Letter Label
Jul 31, 2002	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 3, 2002	Supplement 45Labeling · Standard review	Approved	Letter Label
Mar 7, 2002	Supplement 46Manufacturing · Standard review	Approved	None posted
Dec 5, 2001	Supplement 44Manufacturing · Standard review	Approved	Review
Jun 29, 2001	Supplement 41Manufacturing · Standard review	Approved	Review
May 7, 2001	Supplement 40Manufacturing · Standard review	Approved	None posted
May 1, 2001	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 11, 2001	Supplement 43Manufacturing · Standard review	Approved	Review
Dec 8, 2000	Supplement 42Manufacturing · Standard review	Approved	None posted
Nov 30, 2000	Supplement 33Efficacy (new indication or use)	Approved	Letter Label
Oct 30, 2000	Supplement 39Manufacturing · Standard review	Approved	Review
Jun 20, 2000	Supplement 34Labeling · Standard review	Approved	Review
Jun 2, 2000	Supplement 35Manufacturing · Standard review	Approved	Review
Nov 15, 1999	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 15, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 6, 1999	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Review
Feb 22, 1999	Supplement 30Labeling · Standard review	Approved	Review
Jan 14, 1999	Supplement 27Labeling · Standard review	Approved	Review
Nov 20, 1998	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 27, 1998	Supplement 25Manufacturing · Standard review	Approved	Review
Jul 20, 1998	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jul 20, 1998	Supplement 22Labeling · Standard review	Approved	Letter Review
Jun 23, 1998	Supplement 24Labeling · Standard review	Approved	Review
Jun 11, 1998	Supplement 23Manufacturing · Standard review	Approved	Review
Mar 19, 1998	Supplement 26Manufacturing · Standard review	Approved	Review
Mar 12, 1998	Supplement 16Efficacy (new indication or use)	Approved	Review
Sep 17, 1997	Supplement 17Manufacturing · Standard review	Approved	Review
Sep 17, 1997	Supplement 19Manufacturing · Standard review	Approved	Review
Sep 4, 1997	Supplement 20Manufacturing · Standard review	Approved	Review
Jun 23, 1997	Supplement 18Labeling · Standard review	Approved	Review
Jun 17, 1997	Supplement 13Labeling · Standard review	Approved	None posted
Jun 17, 1997	Supplement 15Labeling · Standard review	Approved	None posted
May 8, 1997	Supplement 11Efficacy (new indication or use)	Approved	None posted
Apr 17, 1997	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 25, 1997	Supplement 9Labeling · Standard review	Approved	Review
Dec 24, 1996	Supplement 12Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 25, 1996	Supplement 7Manufacturing · Standard review	Approved	Review
May 6, 1996	Supplement 5Manufacturing · Standard review	Approved	Review
Apr 8, 1996	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 30, 1996	Supplement 6Labeling · Standard review	Approved	Review
Nov 30, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Oct 18, 1995	Supplement 4Labeling · Standard review	Approved	Review
May 10, 1995	Original applicationNew molecular entity · Standard review	Approved	Review Pediatric Written Request Pediatric Amendment 1 Pediatric Medical Review

Show all 73

Identifiers

Application: NDA 20406
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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