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    01 Celecoxib (1)

    02 Duloxetine (1)

    03 Esomeprazole Magnesium (1)

    04 Fenofibrate (1)

    05 Gabapentin (1)

    06 Metoprolol Succinate (1)

    07 Metoprolol Tartrate (1)

    08 Rosuvastatin Calcium (1)

    09 Sitagliptin Phosphate (2)

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      Duloxetine

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      USDMF

      Found USDMF

      30174
      Active
      DULOXETINE HYDROCHLORIDE USP, NON-S...
      2016-03-07
      CEP/COS

      Found CEP/COS

      R1-CEP 2016-142 - Rev 00
      Valid
      Duloxetine hydrochloride
      2022-03-23
      Japanese DMF

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      Application Number
      30174
      R1-CEP 2016-142 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      DULOXETINE HYDROCHLORIDE USP, NON-S...
      Duloxetine hydrochloride
      Issue/Submission Date
      2016-03-07
      2022-03-23
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        Gabapentin

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        USDMF

        Found USDMF

        37243
        Active
        GABAPENTIN
        2022-10-31
        CEP/COS

        Found CEP/COS

        R0-CEP 2022-303 - Rev 00
        Valid
        Gabapentin, Site Yongtai Chiral
        2022-10-27
        Japanese DMF

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        Application Number
        37243
        R0-CEP 2022-303 - Rev 00
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Filing Details
        GABAPENTIN
        Gabapentin, Site Yongtai Chiral
        Issue/Submission Date
        2022-10-31
        2022-10-27
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          Celecoxib

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          USDMF

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          31101
          Active
          CELECOXIB, USP
          2016-12-06
          CEP/COS

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          Application Number
          31101
          Status
          Active
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          N/A
           
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          CELECOXIB, USP
          Issue/Submission Date
          2016-12-06
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            Esomeprazole Magnesium

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            USDMF

            Found USDMF

            30901
            Active
            ESOMEPRAZOLE MAGNESIUM USP, NON-STE...
            2016-09-15
            CEP/COS

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            Application Number
            30901
            Status
            Active
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            Reviewed
             
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            ESOMEPRAZOLE MAGNESIUM USP, NON-STE...
            Issue/Submission Date
            2016-09-15
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              Fenofibrate

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              USDMF

              Found USDMF

              28999
              Active
              FENOFIBRATE USP
              2015-02-18
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              Application Number
              28999
              Status
              Active
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              Reviewed
               
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              FENOFIBRATE USP
              Issue/Submission Date
              2015-02-18
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                Metoprolol Succinate

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                USDMF

                Found USDMF

                29954
                Active
                METOPROLOL SUCCINATE USP
                2015-11-30
                CEP/COS

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                Application Number
                29954
                Status
                Active
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                METOPROLOL SUCCINATE USP
                Issue/Submission Date
                2015-11-30
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                  Metoprolol Tartrate

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                  USDMF

                  Found USDMF

                  28821
                  Active
                  METOPROLOL TARTRATE USP
                  2014-12-19
                  CEP/COS

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                  Application Number
                  28821
                  Status
                  Active
                  Fees Paid
                  Reviewed
                   
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                  METOPROLOL TARTRATE USP
                  Issue/Submission Date
                  2014-12-19
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                    Rosuvastatin Calcium

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                    USDMF

                    Found USDMF

                    36012
                    Active
                    ROSUVASTATIN CALCIUM USP
                    2021-08-03
                    CEP/COS

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                    Japanese DMF

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                    Application Number
                    36012
                    Status
                    Active
                    Fees Paid
                    N/A
                     
                    Filing Details
                    ROSUVASTATIN CALCIUM USP
                    Issue/Submission Date
                    2021-08-03
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                      Sitagliptin Phosphate

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                      USDMF

                      Found USDMF

                      35727
                      Active
                      INTERMEDIATE OF SITAGLIPTIN PHOSPHA...
                      2021-03-22
                      CEP/COS

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                      Japanese DMF

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                      Application Number
                      35727
                      Status
                      Active
                      Fees Paid
                      N/A
                       
                      Filing Details
                      INTERMEDIATE OF SITAGLIPTIN PHOSPHA...
                      Issue/Submission Date
                      2021-03-22
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                        Sitagliptin Phosphate

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                        USDMF

                        Found USDMF

                        36153
                        Active
                        SITAGLIPTIN PHOSPHATE USP
                        2021-08-12
                        CEP/COS

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                        Japanese DMF

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                        Application Number
                        36153
                        Status
                        Active
                        Fees Paid
                        N/A
                         
                        Filing Details
                        SITAGLIPTIN PHOSPHATE USP
                        Issue/Submission Date
                        2021-08-12
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