Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English