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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

Astrazeneca Pharms
omega-3-carboxylic acids
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?

Expired Orange Book Patents for NDA: 205060

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
omega-3-carboxylic acids
CAPSULE;ORAL205060-001May 5, 20145,792,795<disabled>
Astrazeneca Pharms
omega-3-carboxylic acids
CAPSULE;ORAL205060-001May 5, 20145,948,818<disabled>
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