omega-3-acid ethyl esters
These highlights do not include all the information needed to use OMEGA-3-ACID ETHLY ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHLY ESTERS CAPSULES.OMEGA-3-ACID ETHLY ESTERS capsules, for oral use.Initial U.S. Approval: 2004
Approved
Approval ID
9499c40e-6665-4fbf-914d-1a9931b93562
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2021
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
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 Code64380-761
Application NumberANDA203893
Product Classification
M
Marketing Category
C73584
G
Generic Name
omega-3-acid ethyl esters
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (9)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 900 mg in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT