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

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m disofenin kit. It is available as 1 brand (NDA) application.

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

HEPATOLITE (NDA 018467, SUN PHARM INDS INC) 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 disofenin kit are approved?

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

FDA Orange Book · active-ingredient family

Technetium tc-99m disofenin kit

Technetium tc-99m disofenin kit is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HEPATOLITE · NDA 018467

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HEPATOLITE	SUN PHARM INDS INC	NDA 018467	—	Mar 16, 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 disofenin kit — 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