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Details for New Drug Application (NDA): 205060

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NDA 205060 describes EPANOVA, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are eight patents protecting this drug. Additional details are available on the EPANOVA profile page.

The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.

Summary for NDA: 205060

Formulation / Manufacturing:see details

Summary for product number 001

Approval Date:May 5, 2014TE:RLD:Yes
Patent:5,792,795Patent Expiration:May 13, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:5,948,818Patent Expiration:May 13, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:7,960,370Patent Expiration:Feb 7, 2025Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.