NDC 0173-0783

LOVAZA

Omega-3-acid Ethyl Esters

LOVAZA is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Omega-3-acid Ethyl Esters.

Product ID0173-0783_6ef30e20-23d5-4c2c-a306-19ee5ff63d71
NDC0173-0783
Product TypeHuman Prescription Drug
Proprietary NameLOVAZA
Generic NameOmega-3-acid Ethyl Esters
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2008-10-21
Marketing End Date2019-10-31
Marketing CategoryNDA / NDA
Application NumberNDA021654
Labeler NameGlaxoSmithKline LLC
Substance NameOMEGA-3-ACID ETHYL ESTERS
Active Ingredient Strength900 mg/1
Pharm ClassesFatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC Exclude FlagN

Packaging

NDC 0173-0783-02

120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0783-02)
Marketing Start Date2008-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0783-02 [00173078302]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-10-21
Marketing End Date2019-10-31

NDC 0173-0783-61 [00173078361]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-21
Marketing End Date2012-09-11

NDC 0173-0783-01 [00173078301]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-21
Marketing End Date2012-09-11

NDC 0173-0783-62 [00173078362]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-21
Marketing End Date2015-06-30

Drug Details

Active Ingredients

IngredientStrength
OMEGA-3-ACID ETHYL ESTERS900 mg/1

Pharmacological Class

  • Fatty Acids
  • Omega-3 [CS]
  • Omega-3 Fatty Acid [EPC]

NDC Crossover Matching brand name "LOVAZA" or generic name "Omega-3-acid Ethyl Esters"

NDCBrand NameGeneric Name
0173-0783LOVAZAomega-3-acid ethyl esters
0173-0884LOVAZAomega-3-acid ethyl esters
17856-0084LOVAZAomega-3-acid ethyl esters
17856-0783LOVAZAomega-3-acid ethyl esters
21695-795LOVAZAomega-3-acid ethyl esters
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
0254-3010Omega-3-acid ethyl estersOmega-3-acid ethyl esters
0904-6706Omega-3-acid ethyl estersOmega-3-acid ethyl esters
16714-660Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
17856-0034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
31722-936Omega-3-acid ethyl estersOmega-3-acid ethyl esters
42291-657Omega-3-acid ethyl estersOmega-3-acid ethyl esters
42708-067Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
42806-552OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS
49884-019Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
50090-3421Omega-3-acid ethyl estersOmega-3-acid ethyl esters
50090-3742Omega-3-acid ethyl estersOmega-3-acid ethyl esters
50090-3956Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
50090-3957Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
50090-5799Omega-3-acid ethyl estersOmega-3-acid ethyl esters
50268-676omega-3-acid ethyl estersomega-3-acid ethyl esters
55700-873Omega-3-acid ethyl estersOmega-3-acid ethyl esters
60429-912Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl esters

Trademark Results [LOVAZA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOVAZA
LOVAZA
77189141 3423907 Live/Registered
GLAXOSMITHKLINE LLC
2007-05-24
LOVAZA
LOVAZA
77139246 not registered Dead/Abandoned
Reliant Pharmaceuticals, Inc.
2007-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.