Is there a generic for Indium in-111 pentetate disodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Indium in-111 pentetate disodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Indium in-111 pentetate disodium?

MPI INDIUM DTPA IN 111 (NDA 017707, GE HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Indium in-111 pentetate disodium are approved?

Indium in-111 pentetate disodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Indium in-111 pentetate disodium

Indium in-111 pentetate disodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MPI INDIUM DTPA IN 111 · NDA 017707

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MPI INDIUM DTPA IN 111RLD	GE HEALTHCARE	NDA 017707	—	Feb 18, 1982

Listed patents

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.

Indium in-111 pentetate disodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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