Active substance
Didanosine
- US FDA 9
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VIDEX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, chewable · oral | BRISTOL MYERS SQUIBB | Discontinued | 9 Oct 1991 |
| VIDEX | 100MG/PACKET; 167MG/PACKET; 250MG/PACKET; 375MG/PACKET | for solution · oral | BRISTOL MYERS SQUIBB | Discontinued | 9 Oct 1991 |
| VIDEX | 10MG/ML | for solution · oral | BRISTOL | Discontinued | 9 Oct 1991 |
| VIDEX EC | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule, delayed rel pellets · oral | BRISTOL MYERS SQUIBB | Discontinued | 31 Oct 2000 |
| DIDANOSINE | 200MG; 250MG; 400MG | capsule, delayed rel pellets · oral | BARR | Discontinued | 3 Dec 2004 |
| DIDANOSINE | 10MG/ML | for solution · oral | AUROBINDO PHARMA | Discontinued | 8 Mar 2007 |
| DIDANOSINE | 125MG; 200MG; 250MG; 400MG | capsule, delayed rel pellets · oral | AUROBINDO PHARMA | Discontinued | 24 Sep 2008 |
| DIDANOSINE | 125MG; 200MG; 250MG; 400MG | capsule, delayed rel pellets · oral | PHARMOBEDIENT | Discontinued | 8 Apr 2010 |
| DIDANOSINE | 100MG; 150MG; 200MG | tablet, for suspension · oral | AUROBINDO | Discontinued | 14 Aug 2012 |
Safety signals and safety-related labeling changes
- US FDA 17 Dec 2018 VIDEX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 17 Dec 2018 VIDEX EC — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes - EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.