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

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Technetium tc-99m sestamibi kit, referencing the brand CARDIOLITE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

CARDIOLITE (NDA 019785, SHINE) 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 sestamibi kit are approved?

Technetium tc-99m sestamibi kit is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Technetium tc-99m sestamibi kit

Technetium tc-99m sestamibi kit is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CARDIOLITE · NDA 019785

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CARDIOLITERLD×2	SHINE	NDA 019785	AP	Dec 21, 1990

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
TECHNETIUM TC 99M SESTAMIBI	SUN PHARM INDS INC	ANDA 079157	—	Jul 10, 2009
TECHNETIUM TC 99M SESTAMIBI	JUBILANT DRAXIMAGE	ANDA 078806	AP	Apr 29, 2009
TECHNETIUM TC 99M SESTAMIBI	CARDINAL HEALTH 414	ANDA 078809	AP	Apr 28, 2009
TECHNETIUM TC 99M SESTAMIBI	CURIUM	ANDA 078098	AP	Sep 22, 2008

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 sestamibi kit — frequently asked questions

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

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