Is there a generic for Technetium tc-99m succimer?

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m succimer. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Technetium tc-99m succimer?

NEPHROSCAN (NDA 214993, THERAGNOSTICS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Technetium tc-99m succimer are approved?

Technetium tc-99m succimer is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Technetium tc-99m succimer

Technetium tc-99m succimer is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NEPHROSCAN · NDA 214993

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder

Product	Applicant	Application	TE	Approved
NEPHROSCANRLD	THERAGNOSTICS	NDA 214993	—	Feb 18, 2022

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.

Technetium tc-99m succimer — frequently asked questions

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

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