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Generated: September 23, 2018

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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 205060
Tradename:EPANOVA
Applicant:Astrazeneca Pharms
Ingredient:omega-3-carboxylic acids
Patents:8
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205060
Generic Entry Date for 205060*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
Approval Date:May 5, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:May 5, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:May 13, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 13, 2019Product Flag?YSubstance Flag?Delist Request?

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