Is there a generic for Omega-3-acid ethyl esters type a?

The FDA Orange Book does not currently list an approved generic (ANDA) for Omega-3-acid ethyl esters type a. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Omega-3-acid ethyl esters type a?

OMTRYG (NDA 204977, OSMOTICA PHARM US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Omega-3-acid ethyl esters type a are approved?

Omega-3-acid ethyl esters type a is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Omega-3-acid ethyl esters type a

Omega-3-acid ethyl esters type a is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OMTRYG · NDA 204977

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
OMTRYGRLD	OSMOTICA PHARM US	NDA 204977	—	Apr 23, 2014

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.

Omega-3-acid ethyl esters type a — frequently asked questions

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

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