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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204977

OMTRYG (OMEGA-3-ACID ETHYL ESTERS TYPE A)
1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Marketing Status: Discontinued
Active Ingredient: OMEGA-3-ACID ETHYL ESTERS TYPE A
Proprietary Name: OMTRYG
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204977
Product Number: 001
Approval Date: Apr 23, 2014
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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