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

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Technetium tc-99m pentetate kit, referencing the brand DRAXIMAGE DTPA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

DRAXIMAGE DTPA (NDA 018511, JUBILANT) 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 pentetate kit are approved?

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

FDA Orange Book · active-ingredient family

Technetium tc-99m pentetate kit

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

Reference-listed drug:DRAXIMAGE DTPA · NDA 018511

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DRAXIMAGE DTPARLD	JUBILANT	NDA 018511	AP	Dec 29, 1989
AN-DTPA	JUBILANT DRAXIMAGE	NDA 017714	—	Approved Prior to Jan 1, 1982
MPI DTPA KIT - CHELATE	GE HEALTHCARE	NDA 017255	—	Approved Prior to Jan 1, 1982
TECHNETIUM TC-99M PENTETATE KIT	GE HEALTHCARE	NDA 017264	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
TECHNETIUM TC-99M PENTETATE KIT	CURIUM	ANDA 215146	AP	Mar 26, 2025

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 pentetate kit — frequently asked questions

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

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