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

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

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

TECHNESCAN GLUCEPTATE (NDA 018272, DRAXIMAGE) 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 gluceptate kit are approved?

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

FDA Orange Book · active-ingredient family

Technetium tc-99m gluceptate kit

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

Reference-listed drug:TECHNESCAN GLUCEPTATE · NDA 018272

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TECHNESCAN GLUCEPTATE	DRAXIMAGE	NDA 018272	—	Jan 27, 1982
GLUCOSCAN	BRISTOL MYERS SQUIBB	NDA 017907	—	Approved Prior to Jan 1, 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.

Technetium tc-99m gluceptate kit — frequently asked questions

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

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