FDA Orange Book · active-ingredient family
Didanosine
Didanosine is approved as 4 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VIDEX EC · NDA 021183
4
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed rel pellets, for solution, tablet, chewable, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIDEX ECRLD×4 | BRISTOL MYERS SQUIBB | NDA 021183 | — | Oct 31, 2000 | |
| VIDEXRLD | BRISTOL | NDA 020156 | — | Oct 09, 1991 | |
| VIDEXRLD×5 | BRISTOL MYERS SQUIBB | NDA 020154 | — | Oct 09, 1991 | |
| VIDEX×4 | BRISTOL MYERS SQUIBB | NDA 020155 | — | Oct 09, 1991 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIDANOSINE×3 | AUROBINDO | ANDA 077275 | — | Aug 14, 2012 | |
| DIDANOSINE×4 | PHARMOBEDIENT | ANDA 090788 | — | Apr 08, 2010 | |
| DIDANOSINE×4 | AUROBINDO PHARMA | ANDA 090094 | — | Sep 24, 2008 | |
| DIDANOSINE | AUROBINDO PHARMA | ANDA 078112 | — | Mar 08, 2007 | |
| DIDANOSINE×3 | BARR | ANDA 077167 | — | Dec 03, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Didanosine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
