OMEGA-3-ACID ETHYL ESTERS
These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES. Initial U.S. Approval: 2004
Approved
Approval ID
c8dc6c4a-ed19-4727-ba5a-35075f1ddddf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 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
NDC Product Code71335-2024
Application NumberANDA210093
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 7, 2023
Generic NameOMEGA-3-ACID ETHYL ESTERS
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB