FDA Orange Book · active-ingredient family
Indium in-111 chloride
Indium in-111 chloride: 2 brands, 0 generics; first approved Dec 29, 1992.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- INDIUM IN 111 CHLORIDERLDCURIUMNDA 0198411994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5mCi/0.5ML INJECTABLE INJECTION Discontinued — - INDICLORRLDGE HEALTHCARENDA 0198621992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2mCi/0.2ML INJECTABLE INJECTION 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
34 yr 3 mo ago
Most recent approval
32 yr 6 mo ago
Approvals span 1992–1994 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Indium in-111 chloride: 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.

