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    Approved Drug Products containing UREA C-13 listed in the FDA Orange Book. Original Data : FDA Website

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    UREA, C-13

    APIs // Active Pharmaceutical Ingredients

    DOSSIERs // Finished Dosage Forms

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    01 DXS DEVICES (1)

    02 MERIDIAN BIOSCIENCE (1)

    03 METABOLIC SOLUTIONS (1)

    04 OTSUKA AMERICA (2)

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    01 FOR SOLUTION, TABLET, FOR SOLUTION;ORAL (1)

    02 FOR SOLUTION;ORAL (4)

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    01 DISCN (4)

    02 RX (1)

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    01 BREATHTEK UBT FOR H-PYLORI (1)

    02 HELICOSOL (1)

    03 IDKIT:HP (1)

    04 MERETEK UBT KIT (W/ PRANACTIN) (1)

    05 PYLORI-CHEK BREATH TEST (1)

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    MERIDIAN BIOSCIENCE

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      CITRIC ACID; UREA C-13

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      FOR SOLUTION, TABLET, FOR SOLUTION;ORAL
      4GM;75MG
      2002-12-17
      21314
      IDKIT:HP
      RX
      Yes
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      METABOLIC SOLUTIONS

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        UREA C-13

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        FOR SOLUTION;ORAL
        125MG/VIAL
        1999-12-17
        21092
        HELICOSOL
        DISCN
        No
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        OTSUKA AMERICA

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        UREA C-13

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        FOR SOLUTION;ORAL
        125MG/VIAL
        1996-09-17
        20586
        MERETEK UBT KIT (W/ PR...
        DISCN
        No
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        OTSUKA AMERICA

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        UREA C-13

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        FOR SOLUTION;ORAL
        EQ 75MG/POUCH
        2001-05-10
        20586
        BREATHTEK UBT FOR H-PY...
        DISCN
        No
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        DXS DEVICES

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        UREA C-13

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        FOR SOLUTION;ORAL
        100MG/VIAL
        1999-02-04
        20900
        PYLORI-CHEK BREATH TES...
        DISCN
        No
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