Didanosine

Sold as Videx, Videx Ec. Every FDA application for this active ingredient: 4 branded and 5 generic.

As of Nov 15, 2026, FDA lists 9 applications for Didanosine (sold as Videx, Videx Ec), first approved Oct 9, 1991, with 24 new uses approved and 0 published complete response letters.

First approved: Oct 9, 1991
Applications: 9
New uses approved: 24
Complete response letters: 0

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV TreatmentsHIV-1-infection · Gilead Sciences	Phase 4	Recruiting	Mar 29, 2024
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIVAcquired Immune Deficiency Syndrome (AIDS), HIV Infections · Gilead Sciences	Phase 2 / Phase 3	Active, not recruiting	Dec 20, 2013

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 9, 1991	VidexNDA 20154 · New molecular entity	Bristol Myers Squibb	40	Discontinued
Oct 9, 1991	VidexNDA 20155 · New dosage form	Bristol Myers Squibb	31	Discontinued
Oct 9, 1991	VidexNDA 20156 · New dosage form	Bristol	39	Discontinued
Oct 31, 2000	Videx EcNDA 21183 · New dosage form	Bristol Myers Squibb	17	Discontinued
Dec 3, 2004	DidanosineANDA 77167	Barr	3	Discontinued
Mar 8, 2007	DidanosineANDA 78112	Aurobindo Pharma	3	Discontinued
Sep 24, 2008	DidanosineANDA 90094	Aurobindo Pharma	7	Discontinued
Apr 8, 2010	DidanosineANDA 90788	Pharmobedient	3	Discontinued
Aug 14, 2012	DidanosineANDA 77275	Aurobindo	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA