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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205060

EPANOVA (OMEGA-3-CARBOXYLIC ACIDS)
1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
Marketing Status: Discontinued
Active Ingredient: OMEGA-3-CARBOXYLIC ACIDS
Proprietary Name: EPANOVA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205060
Product Number: 001
Approval Date: May 5, 2014
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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