NDA 20156, held by Bristol. Didanosine.
As of Nov 14, 2026, NDA 20156 (Videx), held by Bristol, was first approved by FDA on Oct 9, 1991, with 39 approved supplements and 0 published complete response letters.
| Apr 1, 2002 | Supplement 29Efficacy (new indication or use) | Approved | |
| Jul 24, 2000 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Oct 28, 1999 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 1999 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 1996 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 1994 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Sep 25, 1992 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Oct 9, 1991 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Videx10MG/ML · for solution;oral | Didanosine | DiscontinuedReference drug |
| Dec 17, 2018 | Supplement 54Labeling · Standard review | Approved | |
| Jan 25, 2018 | Supplement 53Labeling · Standard review | Approved | |
| Aug 8, 2014 | Supplement 51Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 48Labeling | Approved | |
| May 10, 2011 | Supplement 47REMS | Approved | |
| Jan 25, 2010 | Supplement 46REMS | Approved | |
| Jun 11, 2009 | Supplement 44Labeling · Standard review | Approved | |
| Nov 29, 2006 | Supplement 40Labeling · Standard review | Approved | |
| Aug 18, 2006 | Supplement 39Labeling · Standard review | Approved | |
| Jan 21, 2004 | Supplement 35Labeling · Standard review | Approved | |
| Mar 4, 2003 | Supplement 33Labeling · Standard review | Approved | |
| Sep 25, 2002 | Supplement 32Labeling · Standard review | Approved | |
| Sep 25, 2002 | Supplement 31Labeling · Standard review | Approved | |
| Apr 1, 2002 | Supplement 29Efficacy (new indication or use) | Approved | |
| Nov 16, 2001 | Supplement 28Labeling · Standard review | Approved | |
| Sep 10, 2001 | Supplement 27Labeling · Standard review | Approved | |
| Jul 27, 2001 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jul 24, 2000 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2000 | Supplement 24Labeling · Standard review | Approved | |
| Jul 3, 2000 | Supplement 23Labeling · Standard review | Approved | None posted |
| Oct 28, 1999 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 1999 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jun 23, 1998 | Supplement 19Manufacturing | Approved | None posted |
| Apr 23, 1998 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 5, 1998 | Supplement 20Manufacturing | Approved | None posted |
| Jul 17, 1996 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jun 26, 1996 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 26, 1996 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 13, 1996 | Supplement 15Manufacturing | Approved | None posted |
| Aug 21, 1995 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 14, 1995 | Supplement 14Manufacturing | Approved | None posted |
| Jun 15, 1995 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 5, 1994 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Feb 10, 1994 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 10, 1994 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 25, 1992 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Oct 9, 1991 | Original applicationNew dosage form · Priority review | Approved | None posted |
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
