Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Strides Shasun Limited
918513263
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Strides Shasun Limited
Par Pharmaceutical Inc.
Strides Shasun Limited
918513263
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
0254-3010Application Number
ANDA203893Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 25, 2017GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
Code: D87YGH4Z0QClass: ACTIBQuantity: 900 mg in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT