NDA 20977, held by Viiv Hlthcare. Abacavir Sulfate.
As of Nov 13, 2026, NDA 20977 (Ziagen), held by Viiv Hlthcare, was first approved by FDA on Dec 17, 1998, with 30 approved supplements and 0 published complete response letters.
| Mar 23, 2015 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2008 | Supplement 17Efficacy (new indication or use) | Approved | |
| Aug 2, 2004 | Supplement 12Efficacy (new indication or use) | Approved | |
| Apr 15, 2004 | Supplement 11Efficacy (new indication or use) | Approved | |
| Dec 15, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 1998 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZiagenEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Abacavir Sulfate | DiscontinuedReference drug |
| Nov 24, 2020 | Supplement 35Labeling · Standard review | Approved | |
| May 9, 2018 | Supplement 34Labeling · Standard review | Approved | |
| May 9, 2018 | Supplement 33Labeling · Standard review | Approved | |
| Mar 20, 2017 | Supplement 32Labeling · Standard review | Approved | |
| Sep 30, 2015 | Supplement 30Labeling · Standard review | Approved | |
| Jul 21, 2015 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 23, 2015 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Feb 19, 2015 | Supplement 28Labeling · Standard review | Approved | |
| Sep 11, 2013 | Supplement 26Labeling · Standard review | Approved | |
| May 18, 2012 | Supplement 25Labeling · Standard review | Approved | |
| Mar 15, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 23Labeling | Approved | |
| May 13, 2011 | Supplement 22REMS | Approved | |
| Aug 4, 2010 | Supplement 20REMS | Approved | |
| Dec 19, 2008 | Supplement 19Labeling | Approved | |
| Jul 18, 2008 | Supplement 17Efficacy (new indication or use) | Approved | |
| May 7, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Aug 11, 2006 | Supplement 14Labeling · Standard review | Approved | |
| Aug 2, 2004 | Supplement 12Efficacy (new indication or use) | Approved | |
| Jul 26, 2004 | Supplement 13Labeling · Standard review | Approved | |
| Apr 15, 2004 | Supplement 11Efficacy (new indication or use) | Approved | |
| Jul 17, 2003 | Supplement 10Labeling · Standard review | Approved | |
| Oct 2, 2002 | Supplement 7Labeling · Standard review | Approved | |
| Aug 14, 2002 | Supplement 8Labeling · Standard review | Approved | |
| Jun 4, 2002 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 28, 2002 | Supplement 5Labeling · Standard review | Approved | |
| Jul 13, 2001 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Dec 15, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 17, 1998 | 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
