Is there a generic for Ethiodized oil?

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

What is the reference-listed drug for Ethiodized oil?

LIPIODOL (NDA 009190, GUERBET) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethiodized oil are approved?

Ethiodized oil is approved in the following dosage form: oil.

FDA Orange Book · active-ingredient family

Ethiodized oil

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

Reference-listed drug:LIPIODOL · NDA 009190

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · oil

Product	Applicant	Application	TE	Approved
LIPIODOLRLD	GUERBET	NDA 009190	—	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.

Ethiodized oil — 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