FENOFIBRATE TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [FOOD AND DRUG ADMINISTRATION]

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FENOFIBRATE TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [FOOD AND DRUG ADMINISTRATION]
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NDC
Set ID d78d8e2d-2a80-4666-b1c2-73fc7ee7debf
Category INDEXING - WARNING LETTER ALERT
Packager Food and Drug Administration
Generic Name
Product Class
Product Number
Application Number
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  • SPL INDEXING DATA ELEMENTS SECTION

  • SPL UNCLASSIFIED SECTION

    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588722.htm

  • INGREDIENTS AND APPEARANCE
    FENOFIBRATE 
    fenofibrate tablet
    Product Information
    Product TypeItem Code (Source)NDC:43353-248
    Reporting Period20171205-
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1) FENOFIBRATE48 mg
    MONTELUKAST SODIUM 
    montelukast sodium tablet, chewable
    Product Information
    Product TypeItem Code (Source)NDC:43353-252
    Reporting Period20171205-
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E) MONTELUKAST5 mg
    Labeler - Food and Drug Administration (927645523)
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