NDA 21281, held by Takeda Pharms Na. Lansoprazole.
As of Nov 14, 2026, NDA 21281 (Prevacid), held by Takeda Pharms Na, was first approved by FDA on May 3, 2001, with 14 approved supplements and 0 published complete response letters.
| Jun 17, 2004 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 3, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Prevacid15MG/PACKET · for suspension, delayed release;oral | Lansoprazole | Discontinued |
| Prevacid30MG/PACKET · for suspension, delayed release;oral | Lansoprazole | Discontinued |
| Jul 31, 2009 | Supplement 26 | Approved | |
| Oct 28, 2008 | Supplement 24Labeling · Standard review | Approved | |
| Apr 21, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Jun 14, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Apr 12, 2006 | Supplement 17Labeling · Standard review | Approved | |
| Jun 17, 2004 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2004 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 5, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Dec 3, 2002 | Supplement 4Labeling · Standard review | Approved | |
| Dec 3, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 30, 2002 | Supplement 7Labeling · Standard review | Approved | |
| May 3, 2002 | Supplement 2Labeling · Standard review | Approved | |
| Mar 7, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 3, 2001 | 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
