Omega-3-acid ethyl esters
These highlights do not include all the information needed to use , USP safely and effectively. See full prescribing information for , USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004
Approved
Approval ID
33314f42-c95f-4ea3-a10e-e13754650567
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2111
Application NumberANDA090973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omega-3-acid ethyl esters
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2023
FDA Product Classification
INGREDIENTS (11)
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT