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
52d4fc86-227a-4a74-9f42-50fd184714d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
DUNS: 080210964
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 Code24658-350
Application NumberANDA210093
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEGA-3-ACID ETHYL ESTERS
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (7)
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT