Is there a generic for Technetium tc-99m exametazime kit?

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m exametazime kit. It is available as 2 brand (NDA) applications.

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

CERETEC (NDA 019829, 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 Technetium tc-99m exametazime kit are approved?

Technetium tc-99m exametazime kit is approved in the following dosage forms: injectable, powder.

FDA Orange Book · active-ingredient family

Technetium tc-99m exametazime kit

Technetium tc-99m exametazime kit is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CERETEC · NDA 019829

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, powder

Product	Applicant	Application	TE	Approved
CERETECRLD	GE HEALTHCARE	NDA 019829	—	Dec 30, 1988
DRAX EXAMETAZIME	JUBILANT	NDA 208870	—	Aug 17, 2017

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 exametazime kit — frequently asked questions

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

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