Treats active duodenal ulcer. NDA 21428, held by Takeda Pharms USA. Lansoprazole.
As of Nov 14, 2026, NDA 21428 (Prevacid), held by Takeda Pharms USA, was first approved by FDA on Aug 30, 2002, with 26 approved supplements and 0 published complete response letters.
PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. Maintenance of healed duodenal ulcers in adults. Treatment of active benign gastric ulcer in adults. Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. Risk reduction of NSAID-associated gastric ulcer in adults. Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older.
| Oct 28, 2008 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jun 17, 2004 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Prevacid15MG · tablet, orally disintegrating, delayed release;oral | Lansoprazole | RxReference drug |
| Prevacid30MG · tablet, orally disintegrating, delayed release;oral | Lansoprazole | RxReference drug |
| Aug 8, 2023 | Supplement 42Labeling · Standard review | Approved | |
| Mar 4, 2022 | Supplement 41Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 39Labeling · Standard review | Approved | |
| Sep 11, 2020 | Supplement 37Labeling · Standard review | Approved | |
| Jun 7, 2018 | Supplement 35Labeling · Standard review | Approved | |
| Jun 7, 2018 | Supplement 34Labeling · Standard review | Approved | |
| Apr 13, 2018 | Supplement 32Labeling · Standard review | Approved | |
| Oct 18, 2017 | Supplement 31Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 30Labeling · Standard review | Approved | |
| Dec 16, 2015 | Supplement 27Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 28Labeling | Approved | |
| Sep 28, 2012 | Supplement 25Labeling · Standard review | Approved | |
| May 3, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Oct 28, 2011 | Supplement 23Labeling | Approved | |
| Jun 1, 2011 | Supplement 22Labeling · Standard review | Approved | |
| May 20, 2011 | Supplement 24Labeling | Approved | |
| Sep 3, 2010 | Supplement 21Labeling | Approved | |
| May 12, 2010 | Supplement 20Labeling | Approved | |
| Jul 31, 2009 | Supplement 19Labeling · Standard review | Approved | |
| Oct 28, 2008 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2008 | Supplement 13Labeling · Standard review | Approved | |
| Jun 14, 2007 | Supplement 12Labeling · Standard review | Approved | |
| Apr 12, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Jun 17, 2004 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jun 15, 2004 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 5, 2003 | Supplement 1Labeling · Standard review | Approved | |
| Aug 30, 2002 | Original applicationNew dosage form · Standard review | Approved |
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
