FDA Orange Book · active-ingredient family
Gadoteridol
Gadoteridol: 2 brands, 1 generic; first approved Nov 16, 1992; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- BRACCONDA 0214892003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 279.3MG/ML INJECTABLE INJECTION Rx — - BRACCONDA 0201311992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 279.3MG/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (1)
Abbreviated applications
- GADOTERIDOLHAINAN POLYANDA 2187492025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 279.3MG/ML 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
34 yr 5 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 1992–2025 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Gadoteridol: 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.
