Is there a generic for Technetium tc-99m sodium pertechnetate generator?

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m sodium pertechnetate generator. It is available as 5 brand (NDA) applications.

What is the reference-listed drug for Technetium tc-99m sodium pertechnetate generator?

RADIOGENIX SYSTEM (NDA 202158, NORTHSTAR MEDICAL) 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 sodium pertechnetate generator are approved?

Technetium tc-99m sodium pertechnetate generator is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Technetium tc-99m sodium pertechnetate generator

Technetium tc-99m sodium pertechnetate generator is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RADIOGENIX SYSTEM · NDA 202158

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
RADIOGENIX SYSTEMRLD	NORTHSTAR MEDICAL	NDA 202158	—	Feb 08, 2018
ULTRA-TECHNEKOW V4RLD×2	CURIUM	NDA 017243	—	Feb 18, 2014
TECHNELITERLD×2	SHINE	NDA 017771	—	Feb 12, 2014
DRYTECRLD×2	GE HEALTHCARE	NDA 017693	—	Dec 13, 2013
MINITEC	BRACCO	NDA 017339	—	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 sodium pertechnetate generator — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo