Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
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
50090-3956Application Number
ANDA091018Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 16, 2017WATERInactive
Code: 059QF0KO0RClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
Code: D87YGH4Z0QClass: ACTIBQuantity: 900 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT