Is there a generic for Ethanolamine oleate?

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

What is the reference-listed drug for Ethanolamine oleate?

ETHAMOLIN (NDA 019357, QOL MEDCL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethanolamine oleate are approved?

Ethanolamine oleate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ethanolamine oleate

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

Reference-listed drug:ETHAMOLIN · NDA 019357

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ETHAMOLINRLD	QOL MEDCL	NDA 019357	—	Dec 22, 1988

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.

Ethanolamine oleate — frequently asked questions

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

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