Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202057

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VASCEPA (ICOSAPENT ETHYL)
500MG Marketing Status: Prescription

Active Ingredient: ICOSAPENT ETHYL
Proprietary Name: VASCEPA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202057
Product Number: 002
Approval Date: Feb 16, 2017
Applicant Holder Full Name: AMARIN PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

VASCEPA (ICOSAPENT ETHYL)
1GM Marketing Status: Prescription

Active Ingredient: ICOSAPENT ETHYL
Proprietary Name: VASCEPA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202057
Product Number: 001
Approval Date: Jul 26, 2012
Applicant Holder Full Name: AMARIN PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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