LOVAZA
These highlights do not include all the information needed to use LOVAZA safely and effectively. See full prescribing information for LOVAZA. LOVAZA (omega-3-acid ethyl esters) CapsulesInitial U.S. Approval: 2004
Approved
Approval ID
7892fb39-94c6-41cc-b8cd-d9d145180a96
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-795
Application NumberNDA021654
Product Classification
M
Marketing Category
C73594
G
Generic Name
omega-3-acid ethyl esters
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2009
FDA Product Classification
INGREDIENTS (5)
OMEGA-3-ACID ETHYL ESTERSActive
Quantity: 1 g in 1 1
Code: D87YGH4Z0Q
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT