Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
72162-2111Application Number
ANDA090973Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 19, 2023Code: D87YGH4Z0QClass: ACTIBQuantity: 1 g in 1 1
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT