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.OMEGA-3-ACID ETHYL ESTERS capsules, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
769ad170-5d70-4a54-995a-fef95ef503eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2022
Manufacturers
FDA
Lifestar Pharma LLC
DUNS: 080268943
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 capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-423
Application NumberANDA215458
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omega-3-acid ethyl esters capsules
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2022
FDA Product Classification
INGREDIENTS (5)
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT