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

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m sodium pertechnetate. It is available as 3 brand (NDA) applications.

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

SODIUM PERTECHNETATE TC 99M (NDA 017471, 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 sodium pertechnetate are approved?

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

FDA Orange Book · active-ingredient family

Technetium tc-99m sodium pertechnetate

Technetium tc-99m sodium pertechnetate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SODIUM PERTECHNETATE TC 99M · NDA 017471

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
SODIUM PERTECHNETATE TC 99MRLD	GE HEALTHCARE	NDA 017471	—	Approved Prior to Jan 1, 1982
SODIUM PERTECHNETATE TC 99MRLD	MALLINCKRODT	NDA 017725	—	Approved Prior to Jan 1, 1982
SODIUM PERTECHNETATE TC 99M×3	SUN PHARM INDS INC	NDA 017321	—	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 — frequently asked questions

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

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