Orange Book product · Brand (NDA)
VIDEX EC
DIDANOSINE
At a glance
Oct 31, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2000
26 yr ago
Today
Pharmaceutical detail
Active ingredient
DIDANOSINE
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 021183
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1991VIDEXBrand (NDA)
NDA 020156 · BRISTOL
- 1991VIDEXBrand (NDA)
NDA 020155 · BRISTOL MYERS SQUIBB
- 1991VIDEXBrand (NDA)
NDA 020154 · BRISTOL MYERS SQUIBB
- 2012DIDANOSINEGeneric (ANDA)
ANDA 077275 · AUROBINDO
- 2010DIDANOSINEGeneric (ANDA)
ANDA 090788 · PHARMOBEDIENT
- 2008DIDANOSINEGeneric (ANDA)
ANDA 090094 · AUROBINDO PHARMA
- 2007DIDANOSINEGeneric (ANDA)
ANDA 078112 · AUROBINDO PHARMA
- 2004DIDANOSINEGeneric (ANDA)
ANDA 077167 · BARR
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.
