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Product Details for ANDA 211355

OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Marketing Status: Prescription
Active Ingredient: OMEGA-3-ACID ETHYL ESTERS
Proprietary Name: OMEGA-3-ACID ETHYL ESTERS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211355
Product Number: 001
Approval Date: Jul 10, 2019
Applicant Holder Full Name: SOFGEN PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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