Is there a generic for Samarium sm-153 lexidronam pentasodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Samarium sm-153 lexidronam pentasodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Samarium sm-153 lexidronam pentasodium?

QUADRAMET (NDA 020570, LANTHEUS MEDICAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Samarium sm-153 lexidronam pentasodium are approved?

Samarium sm-153 lexidronam pentasodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Samarium sm-153 lexidronam pentasodium

Samarium sm-153 lexidronam pentasodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:QUADRAMET · NDA 020570

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
QUADRAMETRLD	LANTHEUS MEDICAL	NDA 020570	—	Mar 28, 1997

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.

Samarium sm-153 lexidronam pentasodium — frequently asked questions

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

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