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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204977

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NDA 204977 describes OMTRYG, which is a drug marketed by Osmotica 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
Ingredient:omega-3-acid ethyl esters type a
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:Apr 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
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