Details for New Drug Application (NDA): 204977

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NDA 204977 describes OMTRYG, which is a drug marketed by Osmotica Pharm Us and is included in one NDA. Additional details are available on the OMTRYG profile page.

The generic ingredient in OMTRYG is omega-3-acid ethyl esters type a. There are thirteen drug master file entries for this compound. Additional details are available on the omega-3-acid ethyl esters type a profile page.

Summary for 204977

Tradename:	OMTRYG
Applicant:	Osmotica Pharm Us
Ingredient:	omega-3-acid ethyl esters type a
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:	Apr 23, 2014	TE:		RLD:	Yes

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