U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 202057

Expand all

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: AB
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: AB
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
Back to Top