NDA 20154, held by Bristol Myers Squibb. Didanosine.
As of Nov 13, 2026, NDA 20154 (Videx), held by Bristol Myers Squibb, was first approved by FDA on Oct 9, 1991, with 40 approved supplements and 0 published complete response letters.
| Apr 1, 2002 | Supplement 37Efficacy (new indication or use) | Approved | |
| Jul 24, 2000 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Oct 28, 1999 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 1999 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 1996 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 1994 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Sep 25, 1992 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Oct 9, 1991 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Videx25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Didanosine | DiscontinuedReference drug |
| Videx50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Didanosine | DiscontinuedReference drug |
| Videx100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Didanosine | DiscontinuedReference drug |
| Videx150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Didanosine | DiscontinuedReference drug |
| Videx200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Didanosine | DiscontinuedReference drug |
| Nov 29, 2006 | Supplement 50Labeling · Standard review | Approved | |
| Jan 21, 2004 | Supplement 44Labeling · Standard review | Approved | |
| Mar 4, 2003 | Supplement 42Labeling · Standard review | Approved | |
| Sep 25, 2002 | Supplement 41Labeling · Standard review | Approved | |
| Sep 25, 2002 | Supplement 40Labeling · Standard review | Approved | |
| Aug 23, 2002 | Supplement 39Manufacturing | Approved | None posted |
| Apr 1, 2002 | Supplement 37Efficacy (new indication or use) | Approved | |
| Nov 16, 2001 | Supplement 36Labeling · Standard review | Approved | |
| Sep 10, 2001 | Supplement 35Labeling · Standard review | Approved | |
| Jul 27, 2001 | Supplement 34Labeling · Standard review | Approved | None posted |
| Jul 24, 2000 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2000 | Supplement 32Labeling · Standard review | Approved | |
| Jul 3, 2000 | Supplement 31Labeling · Standard review | Approved | None posted |
| Oct 28, 1999 | Supplement 30Manufacturing | Approved | |
| Oct 28, 1999 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Jul 1, 1999 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Nov 25, 1998 | Supplement 27Manufacturing | Approved | None posted |
| Nov 25, 1998 | Supplement 26Manufacturing | Approved | None posted |
| Jun 23, 1998 | Supplement 25Manufacturing | Approved | None posted |
| Apr 23, 1998 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jan 5, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Jul 31, 1996 | Supplement 22Manufacturing | Approved | None posted |
| Jul 17, 1996 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jun 26, 1996 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jun 26, 1996 | Supplement 16Labeling · Standard review | Approved | None posted |
| Mar 13, 1996 | Supplement 19Manufacturing | Approved | None posted |
| Feb 27, 1996 | Supplement 11Manufacturing | Approved | None posted |
| Aug 21, 1995 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 21, 1995 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 14, 1995 | Supplement 18Manufacturing | Approved | None posted |
| Jun 15, 1995 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 5, 1994 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Apr 13, 1994 | Supplement 10Manufacturing | Approved | None posted |
| Feb 10, 1994 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 10, 1994 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 4, 1993 | Supplement 4Manufacturing | Approved | |
| Sep 25, 1992 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Apr 1, 1992 | Supplement 1Manufacturing | Approved | None posted |
| Oct 9, 1991 | Original applicationNew molecular entity · 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
