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    Approved Drug Products containing 03373_FLUKA listed in the FDA Orange Book. Original Data : FDA Website

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    03373_FLUKA

    APIs // Active Pharmaceutical Ingredients

    DOSSIERs // Finished Dosage Forms

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    01 ABRAXIS PHARM (1)

    02 AM REGENT (4)

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    01 INJECTABLE;INJECTION (2)

    02 SOLUTION;INTRAVENOUS (3)

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    01 DISCN (1)

    02 RX (4)

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    01 CUPRIC SULFATE (2)

    02 MULTRYS (1)

    03 TRALEMENT (2)

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    01 No (1)

    02 Yes (4)

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    ABRAXIS PHARM

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      CUPRIC SULFATE

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      INJECTABLE;INJECTION
      EQ 0.4MG COPPER/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      1987-05-05
      19350
      CUPRIC SULFATE
      DISCN
      Yes
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      AM REGENT

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        CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

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        SOLUTION;INTRAVENOUS
        EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)
        2020-07-02
        209376
        TRALEMENT
        RX
        Yes
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          CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

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          SOLUTION;INTRAVENOUS
          EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)
          2020-12-02
          209376
          TRALEMENT
          RX
          Yes
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            CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

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            SOLUTION;INTRAVENOUS
            EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)
            2021-06-30
            209376
            MULTRYS
            RX
            Yes
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              CUPRIC SULFATE

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              INJECTABLE;INJECTION
              EQ 0.4MG COPPER/ML
              2022-12-16
              216324
              CUPRIC SULFATE
              RX
              No
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