Is there a generic for Selenomethionine se-75?

The FDA Orange Book does not currently list an approved generic (ANDA) for Selenomethionine se-75. It is available as 4 brand (NDA) applications.

What is the reference-listed drug for Selenomethionine se-75?

SELENOMETHIONINE SE 75 (NDA 017257, 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 Selenomethionine se-75 are approved?

Selenomethionine se-75 is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Selenomethionine se-75

Selenomethionine se-75 is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SELENOMETHIONINE SE 75 · NDA 017257

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SELENOMETHIONINE SE 75	GE HEALTHCARE	NDA 017257	—	Approved Prior to Jan 1, 1982
SELENOMETHIONINE SE 75	MALLINCKRODT	NDA 017098	—	Approved Prior to Jan 1, 1982
SELENOMETHIONINE SE 75	PHARMALUCENCE	NDA 017322	—	Approved Prior to Jan 1, 1982
SETHOTOPE	BRACCO	NDA 017047	—	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.

Selenomethionine se-75 — 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