Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
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 Code
72189-024Application Number
ANDA090973Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 2, 2019AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: D87YGH4Z0QClass: ACTIBQuantity: 1 g in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT