NDA 21449, held by Gilead. Adefovir Dipivoxil.
As of Nov 14, 2026, NDA 21449 (Hepsera), held by Gilead, was first approved by FDA on Sep 20, 2002, with 12 approved supplements and 0 published complete response letters.
| Dec 19, 2007 | Supplement 11Efficacy (new indication or use) | Approved | |
| Oct 18, 2006 | Supplement 6Efficacy (new indication or use) | Approved | |
| Apr 28, 2006 | Supplement 5Efficacy (new indication or use) | Approved | |
| Aug 19, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Sep 20, 2002 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hepsera10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Adefovir Dipivoxil | DiscontinuedReference drug |
| Dec 28, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Feb 20, 2014 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Oct 4, 2013 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Nov 29, 2012 | Supplement 20Labeling · Standard review | Approved | |
| Feb 29, 2012 | Supplement 18Labeling | Approved | |
| Oct 16, 2009 | Supplement 16Labeling · Standard review | Approved | |
| May 27, 2008 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 19, 2007 | Supplement 11Efficacy (new indication or use) | Approved | |
| Oct 18, 2006 | Supplement 6Efficacy (new indication or use) | Approved | |
| Sep 20, 2006 | Supplement 9Labeling · Standard review | Approved | |
| Apr 28, 2006 | Supplement 5Efficacy (new indication or use) | Approved | |
| Aug 19, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Sep 20, 2002 | Original applicationNew molecular entity · Priority 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
