FDA Orange Book · active-ingredient family
Didanosine
Didanosine: 4 brands, 5 generics; first approved Oct 09, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
5
Listed patents
0
Presentations
29
Brand (NDA) products
Originator applications
- VIDEX ECRLDBRISTOL MYERS SQUIBBNDA 02118320004 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 200MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 250MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 400MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - VIDEXRLDBRISTOLNDA 0201561991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML FOR SOLUTION ORAL Discontinued — - VIDEXRLDBRISTOL MYERS SQUIBBNDA 02015419915 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET, CHEWABLE ORAL Discontinued — 50MG TABLET, CHEWABLE ORAL Discontinued — 100MG TABLET, CHEWABLE ORAL Discontinued — 150MG TABLET, CHEWABLE ORAL Discontinued — 200MG TABLET, CHEWABLE ORAL Discontinued — - BRISTOL MYERS SQUIBBNDA 02015519914 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/PACKET FOR SOLUTION ORAL Discontinued — 167MG/PACKET FOR SOLUTION ORAL Discontinued — 250MG/PACKET FOR SOLUTION ORAL Discontinued — 375MG/PACKET FOR SOLUTION ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- DIDANOSINEAUROBINDOANDA 07727520123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, FOR SUSPENSION ORAL Discontinued — 150MG TABLET, FOR SUSPENSION ORAL Discontinued — 200MG TABLET, FOR SUSPENSION ORAL Discontinued — - DIDANOSINEPHARMOBEDIENTANDA 09078820104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 200MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 250MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 400MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DIDANOSINEAUROBINDO PHARMAANDA 09009420084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 200MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 250MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 400MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DIDANOSINEAUROBINDO PHARMAANDA 0781122007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML FOR SOLUTION ORAL Discontinued — - DIDANOSINEBARRANDA 07716720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 250MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued — 400MG CAPSULE, DELAYED REL PELLETS ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
35 yr 5 mo ago
Most recent approval
14 yr 3 mo ago
Approvals span 1991–2012 across 9 FDA applications.
Brand (NDA) 444%
Generic (ANDA) 556%
Didanosine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
