Basis of Strength
Strength
icosapent ethyl (UNII: 6GC8A4PAYH) (icosapent - UNII:AAN7QOV9EA) icosapent ethyl 500 mg
Inactive Ingredients
Ingredient Name
Strength
Tocopherol (UNII: R0ZB2556P8) 1 mg
Gelatin, Unspecified (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Maltitol (UNII: D65DG142WK)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL (OVAL) Size 15mm
Flavor Imprint Code V500
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:52937-003-40 240 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2016
2NDC:52937-003-16 1 in 1 CARTON 09/16/2016
216 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Appication Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA202057 09/16/2016
Labeler - Amarin Pharma Inc. (896179731)
Establishment
Name
Address
ID/FEI
Business Operations
Nisshin Pharma Inc 715804535 API MANUFACTURE(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
Patheon Softgels BV 417524097 ANALYSIS(52937-001, 52937-101, 52937-003) , MANUFACTURE(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
AndersonBrecon Packaging Inc 053217022 PACK(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
Packaging Coordinators, Inc. 078525133 PACK(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
Catalent Pharma Solutions 014167995 ANALYSIS(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
Chemport Inc. 688330257 API MANUFACTURE(52937-001, 52937-101, 52937-003)
Establishment
Address
ID/FEI
Business Operations
BASF Pharma (Callanish) Ltd 347031333 API MANUFACTURE(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
Catalent Pharma Solutions, LLC 051762268 MANUFACTURE(52937-001, 52937-101)
Establishment
Name
Address
ID/FEI
Business Operations
Covance Laboratories 213137276 ANALYSIS(52937-001, 52937-101, 52937-003)
Establishment
Name
Address
ID/FEI
Business Operations
