Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Mankind Pharma Limited
915834068
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Softgel Healthcare Private Limited
Lifestar Pharma LLC
Mankind Pharma Limited
675584180
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
70756-423Application Number
ANDA215458Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 10, 2022Code: D87YGH4Z0QClass: ACTIBQuantity: 1 g in 1 1
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT