OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS
Approved
Approval ID
8f274c0a-3072-8233-e053-2a95a90aa0bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-024
Application NumberANDA090973
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEGA-3-ACID ETHYL ESTERS
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2019
FDA Product Classification
INGREDIENTS (11)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT