NDA 50757, held by Takeda Pharms USA. Amoxicillin; Clarithromycin; Lansoprazole.
As of Nov 13, 2026, NDA 50757 (Prevpac (Copackaged)), held by Takeda Pharms USA, was first approved by FDA on Dec 2, 1997, with 22 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 1999 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 2, 1997 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prevpac (Copackaged)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, tablet, capsule, delayed rel pellets;oral | Amoxicillin; Clarithromycin; Lansoprazole | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2018 | Supplement 22Labeling · Standard review | Approved | |
| Nov 29, 2017 | Supplement 21Labeling · Standard review | Approved | |
| Mar 1, 2017 | Supplement 18Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 20Labeling | Approved | |
| Dec 19, 2014 | Supplement 19Labeling | Approved | |
| Nov 6, 2013 | Supplement 17Labeling | Approved | |
| Apr 1, 2009 | Supplement 16Labeling · Standard review | Approved | |
| Oct 30, 2007 | Supplement 15Labeling · Standard review | Approved | |
| May 31, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Aug 9, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Aug 9, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Apr 20, 2005 | Supplement 11Labeling · Standard review | Approved | |
| Jul 27, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Jul 27, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Nov 22, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Nov 22, 2002 | Supplement 8Labeling · Standard review | Approved | |
| Mar 12, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 27, 2001 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1999 | Supplement 4Manufacturing · Standard review | Approved | |
| Aug 20, 1999 | Supplement 3Manufacturing · Standard review | Approved | |
| Jan 22, 1999 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 9, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1997 | Original applicationNew combination · 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
