Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LOVAZA
Product Details
NDC Product Code
21695-795Application Number
NDA021654Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 24, 2009Code: D87YGH4Z0QClass: ACTIBQuantity: 1 g in 1 1
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT