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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by S.a.l.a.r.s. S.p.a. It 22100 Como

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    S.A.L.A.R.S. S.p.A. IT 22100 Como

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    01 Codeine Phosphate (1)

    02 Dihydrocodeine Tartrate (1)

    03 Morphine Hydrochloride (1)

    04 Morphine Sulfate (1)

    05 Naloxone Hydrochloride (1)

    06 Naltrexone Hydrochloride (1)

    07 Oxycodone Hydrochloride (1)

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    01 Blank (7)

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    01 Valid (7)

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      Codeine Phosphate

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2007-064 - Rev 00
      Valid
      Codeine phosphate hemihydrate
      2013-10-04
      Japanese DMF

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      Application Number
      R1-CEP 2007-064 - Rev 00
      Status
      Valid
       
      Filing Details
      Codeine phosphate hemihydrate
      Issue/Submission Date
      2013-10-04
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        Dihydrocodeine Tartrate

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        USDMF

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        CEP/COS

        Found CEP/COS

        R1-CEP 2004-187 - Rev 01
        Valid
        Dihydrocodeine hydrogen tartrate
        2011-04-08
        Japanese DMF

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        Application Number
        R1-CEP 2004-187 - Rev 01
        Status
        Valid
         
        Filing Details
        Dihydrocodeine hydrogen tartrate
        Issue/Submission Date
        2011-04-08
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          Morphine Hydrochloride

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          USDMF

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          CEP/COS

          Found CEP/COS

          R1-CEP 2009-339 - Rev 00
          Valid
          Morphine hydrochloride trihydrate
          2016-04-08
          Japanese DMF

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          Application Number
          R1-CEP 2009-339 - Rev 00
          Status
          Valid
           
          Filing Details
          Morphine hydrochloride trihydrate
          Issue/Submission Date
          2016-04-08
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            Morphine Sulfate

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            USDMF

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            CEP/COS

            Found CEP/COS

            R1-CEP 2011-118 - Rev 01
            Valid
            Morphine hemisulfate 2.5-hydrate
            2016-10-28
            Japanese DMF

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            Written Confirmation

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            Application Number
            R1-CEP 2011-118 - Rev 01
            Status
            Valid
             
            Filing Details
            Morphine hemisulfate 2.5-hydrate
            Issue/Submission Date
            2016-10-28
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              Naloxone Hydrochloride

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              USDMF

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              CEP/COS

              Found CEP/COS

              R1-CEP 2009-310 - Rev 00
              Valid
              Naloxone hydrochloride dihydrate
              2016-02-15
              Japanese DMF

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              Written Confirmation

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              Application Number
              R1-CEP 2009-310 - Rev 00
              Status
              Valid
               
              Filing Details
              Naloxone hydrochloride dihydrate
              Issue/Submission Date
              2016-02-15
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                Naltrexone Hydrochloride

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                USDMF

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                CEP/COS

                Found CEP/COS

                R1-CEP 2006-117 - Rev 02
                Valid
                Naltrexone hydrochloride
                2017-05-05
                Japanese DMF

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                Written Confirmation

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                Application Number
                R1-CEP 2006-117 - Rev 02
                Status
                Valid
                 
                Filing Details
                Naltrexone hydrochloride
                Issue/Submission Date
                2017-05-05
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                  Oxycodone Hydrochloride

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                  USDMF

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                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2013-067 - Rev 00
                  Valid
                  Oxycodone hydrochloride
                  2020-09-10
                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  R1-CEP 2013-067 - Rev 00
                  Status
                  Valid
                   
                  Filing Details
                  Oxycodone hydrochloride
                  Issue/Submission Date
                  2020-09-10
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