FDA Orange Book · active-ingredient family
Indium in-111 oxyquinoline
Indium in-111 oxyquinoline: 1 brand, 1 generic; first approved Dec 24, 1985; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- INDIUM IN 111 OXYQUINOLINERLDRSGE HEALTHCARENDA 0190441985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1mCi/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (1)
Abbreviated applications
- INDIUM IN 111 OXYQUINOLINEBWXT ITGANDA 2025862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1mCi/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
41 yr 5 mo ago
Most recent approval
8 yr 4 mo ago
Approvals span 1985–2018 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Indium in-111 oxyquinoline: 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.
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- 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.
