| Product NDC: | 35356-104 | 
| Proprietary Name: | LOVAZA | 
| Non Proprietary Name: | omega-3-acid ethyl esters | 
| Active Ingredient(s): | 1 g/1 & nbsp; omega-3-acid ethyl esters | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | CAPSULE, LIQUID FILLED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 35356-104 | 
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA021654 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20081021 | 
| Package NDC: | 35356-104-01 | 
| Package Description: | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (35356-104-01) | 
| NDC Code | 35356-104-01 | 
| Proprietary Name | LOVAZA | 
| Package Description | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (35356-104-01) | 
| Product NDC | 35356-104 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | omega-3-acid ethyl esters | 
| Dosage Form Name | CAPSULE, LIQUID FILLED | 
| Route Name | ORAL | 
| Start Marketing Date | 20081021 | 
| Marketing Category Name | NDA | 
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Substance Name | OMEGA-3-ACID ETHYL ESTERS | 
| Strength Number | 1 | 
| Strength Unit | g/1 | 
| Pharmaceutical Classes |