Is there a generic for Technetium tc-99m sulfur colloid?

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

What is the reference-listed drug for Technetium tc-99m sulfur colloid?

TECHNETIUM TC 99M SULFUR COLLOID (NDA 017456, 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 sulfur colloid are approved?

Technetium tc-99m sulfur colloid is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Technetium tc-99m sulfur colloid

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

Reference-listed drug:TECHNETIUM TC 99M SULFUR COLLOID · NDA 017456

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
TECHNETIUM TC 99M SULFUR COLLOID	GE HEALTHCARE	NDA 017456	—	Approved Prior to Jan 1, 1982
TECHNETIUM TC 99M SULFUR COLLOID	MALLINCKRODT	NDA 017724	—	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 sulfur colloid — frequently asked questions

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

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