Is there a generic for Safflower oil?

The FDA Orange Book does not currently list an approved generic (ANDA) for Safflower oil. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Safflower oil?

LIPOSYN 10% (NDA 018203, ABBOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Safflower oil are approved?

Safflower oil is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Safflower oil

Safflower oil is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LIPOSYN 10% · NDA 018203

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
LIPOSYN 10%	ABBOTT	NDA 018203	—	Approved Prior to Jan 1, 1982
LIPOSYN 20%	ABBOTT	NDA 018614	—	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.

Safflower oil — frequently asked questions

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

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