NDA 21183, held by Bristol Myers Squibb. Didanosine.
As of Nov 14, 2026, NDA 21183 (Videx Ec), held by Bristol Myers Squibb, was first approved by FDA on Oct 31, 2000, with 17 approved supplements and 0 published complete response letters.
| Sep 29, 2008 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Apr 1, 2002 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jan 29, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2000 | Original applicationNew dosage form · Priority review | Approved |
| Videx Ec125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed rel pellets;oral | Didanosine | DiscontinuedReference drug |
| Videx Ec200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed rel pellets;oral | Didanosine | DiscontinuedReference drug |
| Videx Ec250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed rel pellets;oral | Didanosine | DiscontinuedReference drug |
| Videx Ec400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed rel pellets;oral | Didanosine | DiscontinuedReference drug |
| Dec 17, 2018 | Supplement 29Labeling · Standard review | Approved | |
| Jan 25, 2018 | Supplement 28Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 25Labeling | Approved | |
| May 10, 2011 | Supplement 24REMS | Approved | |
| Jan 25, 2010 | Supplement 23REMS | Approved | |
| Jun 10, 2009 | Supplement 22Labeling · Standard review | Approved | |
| Sep 29, 2008 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Nov 29, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Aug 18, 2006 | Supplement 15Labeling · Standard review | Approved | |
| Jan 21, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Mar 4, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Oct 16, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Oct 16, 2002 | Supplement 5Labeling · Standard review | Approved | |
| Aug 5, 2002 | Supplement 4Labeling · Standard review | Approved | |
| Apr 1, 2002 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jan 29, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Oct 31, 2000 | Original applicationNew dosage form · 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
