Is there a generic for Evans blue?

The FDA Orange Book does not currently list an approved generic (ANDA) for Evans blue. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Evans blue?

EVANS BLUE (NDA 008041, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Evans blue are approved?

Evans blue is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Evans blue

Evans blue is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:EVANS BLUE · NDA 008041

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
EVANS BLUE	PARKE DAVIS	NDA 008041	—	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.

Evans blue — 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