NDC 17856-0783

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 Atlantic Biologicals Corps. The primary component is Omega-3-acid Ethyl Esters.

Product ID17856-0783_7cc7dd8e-0094-446c-8d32-d3c706b92c78
NDC17856-0783
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 CategoryNDA / NDA
Application NumberNDA021654
Labeler NameAtlantic Biologicals Corps
Substance NameOMEGA-3-ACID ETHYL ESTERS
Active Ingredient Strength900 mg/1
Pharm ClassesFatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0783-2

1 CAPSULE, LIQUID FILLED in 1 CUP (17856-0783-2)
Marketing Start Date2015-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0783-9 [17856078309]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-03
Inactivation Date2020-01-31

NDC 17856-0783-2 [17856078302]

LOVAZA CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA021654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OMEGA-3-ACID ETHYL ESTERS900 mg/1

OpenFDA Data

SPL SET ID:e8adf027-a288-43bf-961d-088fe1028047
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577208
  • 607044

    • 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
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