FDA — authorised 9 October 1991
- Application: NDA020156
- Marketing authorisation holder: BRISTOL
- Local brand name: VIDEX
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Videx in United States
FDA authorised Videx on 9 October 1991
Marketing authorisations
FDA — authorised 9 October 1991
- Application: NDA020155
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: VIDEX
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 9 October 1991
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
FDA — authorised 3 December 2004
- Application: ANDA077167
- Marketing authorisation holder: BARR
- Local brand name: DIDANOSINE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 8 March 2007
- Application: ANDA078112
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DIDANOSINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 24 September 2008
- Application: ANDA090094
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DIDANOSINE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 8 April 2010
- Application: ANDA090788
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DIDANOSINE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
Videx in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Videx approved in United States?
Yes. FDA authorised it on 9 October 1991; FDA authorised it on 9 October 1991; FDA authorised it on 9 October 1991.
Who is the marketing authorisation holder for Videx in United States?
BRISTOL holds the US marketing authorisation.