FDA Orange Book · active-ingredient family
Iodixanol
Iodixanol: 2 brands, 1 generic; first approved Mar 22, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- GE HEALTHCARENDA 02035119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 55% INJECTABLE INJECTION Rx AP 65.2% INJECTABLE INJECTION Rx AP - GE HEALTHCARENDA 02080819972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 55% INJECTABLE INJECTION Discontinued — 65.2% INJECTABLE INJECTION Rx —
Generic (ANDA) products (1)
Abbreviated applications
- IODIXANOLHENGRUI PHARMAANDA 21427120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 55% INJECTABLE INJECTION Rx AP 65.2% INJECTABLE INJECTION Rx AP
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
31 yr ago
Most recent approval
4 yr 5 mo ago
Approvals span 1996–2022 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Iodixanol: 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.
