Omega-3-Acid Ethyl Esters
These highlights do not include all the information needed to use Omega-3-acid ethyl esters safely and effectively. See full prescribing information for Omega-3-acid ethyl esters capsules.Omega-3-Acid Ethyl Esters Capsules, USP for oral useInitial U.S. Approval: 2004
Approved
Approval ID
c9f470e5-ef40-4316-a767-a6d8866834d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
omega-3-acid ethyl esters
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-3957
Application NumberANDA091018
Product Classification
M
Marketing Category
C73584
G
Generic Name
omega-3-acid ethyl esters
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2020
FDA Product Classification
INGREDIENTS (11)
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 900 mg in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT