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FDA Orange Book · active-ingredient family

Indium in-111 pentetreotide kit

Indium in-111 pentetreotide kit: 1 brand, 1 generic; first approved Jun 02, 1994; generic available.

Generic availableHas discontinued products
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
  • NDA 0203141994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3mCi/MLINJECTABLEINJECTIONRx—

Generic (ANDA) products (1)

Abbreviated applications
  • INDIUM IN-111 PENTETREOTIDE KIT
    ANDA 2127852024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    3mCi/MLINJECTABLEINJECTIONDiscontinued—

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
32 yr 10 mo ago
Most recent approval
2 yr 4 mo ago

Approvals span 1994–2024 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Indium in-111 pentetreotide kit: 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.

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