| Product NDC: | 55154-1134 |
| 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: | 55154-1134 |
| Labeler Name: | Cardinal Health |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021654 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20081021 |
| Package NDC: | 55154-1134-0 |
| Package Description: | 10 POUCH in 1 BAG (55154-1134-0) > 1 CAPSULE, LIQUID FILLED in 1 POUCH |
| NDC Code | 55154-1134-0 |
| Proprietary Name | LOVAZA |
| Package Description | 10 POUCH in 1 BAG (55154-1134-0) > 1 CAPSULE, LIQUID FILLED in 1 POUCH |
| Product NDC | 55154-1134 |
| 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 | Cardinal Health |
| Substance Name | OMEGA-3-ACID ETHYL ESTERS |
| Strength Number | 1 |
| Strength Unit | g/1 |
| Pharmaceutical Classes | Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] |