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    01 Alfuzosin HCl (1)

    02 Avibactam Sodium (1)

    03 Azilsartan (1)

    04 Dabigatran Etexilate Mesylate (1)

    05 Dimethyl Fumarate (1)

    06 Dolutegravir Sodium (1)

    07 Doxazosin Mesylate (1)

    08 Empagliflozin (1)

    09 Gadobutrol (1)

    10 Levocetirizine Dihydrochloride (1)

    11 Oclacitinib Maleate (1)

    12 Prazosin Hydrochloride (1)

    13 Pregabalin (1)

    14 Ranolazine (1)

    15 Relebactam (1)

    16 Ropinirole Hydrochloride (1)

    17 Sitagliptin Hydrochloride (1)

    18 Sitagliptin Phosphate (1)

    19 Solithromycin (1)

    20 Sugammadex Sodium (1)

    21 Vonoprazan Fumarate (1)

    22 Ziprasidone Hydrochloride (1)

    23 Ziprasidone Mesylate Trihydrate (1)

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    01 Active (3)

    02 Blank (20)

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    01 Valid (2)

    02 Blank (21)

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    01 303MF10007 (1)

    02 Blank (22)

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    01 WC-0441 (2)

    02 WC-0441A1 (1)

    03 WC-0441A2 (1)

    04 Blank (19)

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      Pregabalin

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      USDMF

      Found USDMF

      33522
      Active
      PREGABALIN USP
      2019-03-19
      CEP/COS

      Found CEP/COS

      CEP 2019-046 - Rev 03
      Valid
      Pregabalin
      2023-10-24
      Japanese DMF

      Found JDMF

      303MF10007
      Pregabalin at 8-2-120/45/A/2, Lane ...
      2021-01-14
      Written Confirmation

      Caution WC

      Indian CDSCO WC-0441
      Expired
      Pregablin EP at 8-2-120/45/A/2, Lan...
      2019-04-08
      Application Number
      33522
      CEP 2019-046 - Rev 03
      303MF10007
      Indian CDSCO WC-0441
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Expired
      2022-04-08
      Filing Details
      PREGABALIN USP
      Pregabalin
      Pregabalin at 8-2-120/45/A/2, Lane ...
      Pregablin EP at 8-2-120/45/A/2, Lan...
      Issue/Submission Date
      2019-03-19
      2023-10-24
      2021-01-14
      2019-04-08
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        Sitagliptin Phosphate

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        USDMF

        Found USDMF

        37020
        Active
        SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
        2022-05-07
        CEP/COS

        Found CEP/COS

        CEP 2022-214 - Rev 00
        Valid
        Sitagliptin phosphate monohydrate
        2024-03-15
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        37020
        CEP 2022-214 - Rev 00
        Status
        Active
        Fees Unpaid
        N/A
        Valid
         
        Filing Details
        SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
        Sitagliptin phosphate monohydrate
        Issue/Submission Date
        2022-05-07
        2024-03-15
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          Ranolazine

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          USDMF

          Found USDMF

          33030
          Active
          RANOLAZINE
          2018-10-22
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Caution WC

          Indian CDSCO WC-0441
          Expired
          Ranolazine IH at 8-2-120/45/A/2, La...
          2019-04-08
          Application Number
          33030
          Indian CDSCO WC-0441
          Status
          Active
          Fees Unpaid
          N/A
           
          Expired
          2022-04-08
          Filing Details
          RANOLAZINE
          Ranolazine IH at 8-2-120/45/A/2, La...
          Issue/Submission Date
          2018-10-22
          2019-04-08
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            Levocetirizine Dihydrochloride

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            USDMF

            Close USDMF

            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0441A1
            Expired
            Levocetirizine Dihydrochloride USP ...
            2020-03-26
            Application Number
            Indian CDSCO WC-0441A1
            Status
             
            Expired
            2022-04-07
            Filing Details
            Levocetirizine Dihydrochloride USP ...
            Issue/Submission Date
            2020-03-26
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              Sugammadex Sodium

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              USDMF

              Close USDMF

              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Caution WC

              Indian CDSCO WC-0441A2
              Expired
              Sugammadex Sodium IH at Unit-II, Su...
              2022-01-04
              Application Number
              Indian CDSCO WC-0441A2
              Status
               
              Expired
              2022-04-07
              Filing Details
              Sugammadex Sodium IH at Unit-II, Su...
              Issue/Submission Date
              2022-01-04
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                Alfuzosin HCl

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                USDMF

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                CEP/COS

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                  Avibactam Sodium

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                  USDMF

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                  CEP/COS

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                    Azilsartan

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                    USDMF

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                    CEP/COS

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                    Japanese DMF

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                      Dabigatran Etexilate Mesylate

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                      USDMF

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                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

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                        Dimethyl Fumarate

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                        USDMF

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                        CEP/COS

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                        Japanese DMF

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