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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Kern Pharma S.l.

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    01 Alfentanil Hydrochloride (1)

    02 Fentanyl (1)

    03 Fentanyl Citrate (1)

    04 Remifentanil (1)

    05 Sufentanil Citrate (2)

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    01 Blank (6)

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    01 Valid (5)

    02 Withdrawn by Holder (1)

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    01 226MF10170 (1)

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      Fentanyl Citrate

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2005-068 - Rev 01
      Valid
      Fentanyl citrate
      2013-01-15
      Japanese DMF

      Found JDMF

      226MF10217
      Fentanyl citrate at Pol. Ind. Colo(...
      2014-11-17
      Written Confirmation

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      Application Number
      R1-CEP 2005-068 - Rev 01
      226MF10217
      Status
      Valid
       
      Filing Details
      Fentanyl citrate
      Fentanyl citrate at Pol. Ind. Colo(...
      Issue/Submission Date
      2013-01-15
      2014-11-17
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        Remifentanil

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        USDMF

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        CEP/COS

        Found CEP/COS

        R1-CEP 2017-065 - Rev 00
        Valid
        Remifentanil hydrochloride
        2023-01-20
        Japanese DMF

        Found JDMF

        226MF10170
        Remifentanil hydrochloride at Pol. ...
        2014-09-01
        Written Confirmation

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        Application Number
        R1-CEP 2017-065 - Rev 00
        226MF10170
        Status
        Valid
         
        Filing Details
        Remifentanil hydrochloride
        Remifentanil hydrochloride at Pol. ...
        Issue/Submission Date
        2023-01-20
        2014-09-01
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          Alfentanil Hydrochloride

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          CEP/COS

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          R1-CEP 2013-139 - Rev 00
          Valid
          Alfentanil hydrochloride hydrate
          2020-01-16
          Japanese DMF

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          Application Number
          R1-CEP 2013-139 - Rev 00
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          Alfentanil hydrochloride hydrate
          Issue/Submission Date
          2020-01-16
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            Fentanyl

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            USDMF

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            CEP/COS

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            R1-CEP 2008-136 - Rev 00
            Valid
            Fentanyl
            2014-07-22
            Japanese DMF

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            Written Confirmation

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            Application Number
            R1-CEP 2008-136 - Rev 00
            Status
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            Fentanyl
            Issue/Submission Date
            2014-07-22
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              Sufentanil Citrate

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              USDMF

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              CEP/COS

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              R0-CEP 2020-088 - Rev 01
              Valid
              Sufentanil citrate
              2023-05-22
              Japanese DMF

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              Written Confirmation

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              Application Number
              R0-CEP 2020-088 - Rev 01
              Status
              Valid
               
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              Sufentanil citrate
              Issue/Submission Date
              2023-05-22
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                Sufentanil Citrate

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                USDMF

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                CEP/COS

                Caution CEP/COS

                R1-CEP 2012-327 - Rev 00
                Withdrawn by Holder
                Sufentanil citrate
                2019-07-04
                Japanese DMF

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                Application Number
                R1-CEP 2012-327 - Rev 00
                Status
                Withdrawn by Holder
                 
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                Sufentanil citrate
                Issue/Submission Date
                2019-07-04
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