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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Mitsubishi Tanabe Pharma

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    01 1,2,3,4-Tetrahydroisoquinoline-3-Carboxylic Acid (1)

    02 2-Butyl-1H-Imidazole-4-Carbaldehyde (1)

    03 Amino Acids Mixture (4)

    04 Argatroban (1)

    05 Argatroban Monohydrate (2)

    06 Aspartic Acid API (1)

    07 Aspirin (1)

    08 Aspirin Lysinate (1)

    09 Cholebine (1)

    10 Coleneuramide (1)

    11 DL-Valine API (1)

    12 Diltiazem Hydrochloride (2)

    13 Diltiazem Malate (1)

    14 Divalproex Sodium (1)

    15 Dl-Carnitine Hydrochloride (1)

    16 Dl-Histidine Monohydrochloride Monohydrate (1)

    17 Dl-Phenylalanine (1)

    18 Dl-Threonine (1)

    19 Dl-Tryptophan (1)

    20 Glycine (1)

    21 Isoleucine (2)

    22 L-Alanine API (2)

    23 L-Arginine (1)

    24 L-Arginine Hydrochloride API (1)

    25 L-Asparagine Monohydrate (1)

    26 L-Cysteine Hydrochloride (1)

    27 L-Glutamic Acid (1)

    28 L-Glutamine (1)

    29 L-Histidine (1)

    30 L-Leucine API (1)

    31 L-Lysine Hydrochloride (1)

    32 L-Threonine (2)

    33 L-Tyrosine API (1)

    34 L-Tyrosine Ethyl Ester Hydrochloride (1)

    35 L-VALINE (1)

    36 Lysine (1)

    37 Lysine Acetate (1)

    38 Methionine (1)

    39 Netoglitazone (1)

    40 Osemozotan Hydrochloride (1)

    41 Phenylalanine (1)

    42 Polyvinyl Alcohol API (2)

    43 Proline (1)

    44 Serine (1)

    45 Ta 3090 (1)

    46 Thiopental Sodium (2)

    47 Thyrotropin-Releasing Hormone (1)

    48 Tryptophan (1)

    49 Ursodeoxycholic Acid (1)

    50 Blank (11)

    filter

    01 Active (1)

    02 Inactive (61)

    03 Blank (8)

    filter

    01 Valid (3)

    02 Withdrawn by Holder (1)

    03 Blank (66)

    filter

    01 222MF10221 (1)

    02 228MF10013 (1)

    03 229MF10027 (1)

    04 Blank (67)

    filter

    01 Blank (70)

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    • FDA
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    Argatroban Monohydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10221
    Argatroban hydrate at 3-16-89 Kashi...
    2010-08-23
    Written Confirmation

    Close WC

    Application Number
    222MF10221
    Status
     
    Filing Details
    Argatroban hydrate at 3-16-89 Kashi...
    Issue/Submission Date
    2010-08-23
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    Argatroban Monohydrate

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    228MF10013
    Argatroban hydrate at 3-2-10 Doshom...
    2016-01-08
    Written Confirmation

    Close WC

    Application Number
    228MF10013
    Status
     
    Filing Details
    Argatroban hydrate at 3-2-10 Doshom...
    Issue/Submission Date
    2016-01-08
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    Diltiazem Hydrochloride

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    USDMF

    Caution USDMF

    3059
    Inactive
    DILTIAZEM HCL
    1977-11-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-177 - Rev 05
    Withdrawn by Holder
    Diltiazem hydrochloride
    2015-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3059
    R1-CEP 2001-177 - Rev 05
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DILTIAZEM HCL
    Diltiazem hydrochloride
    Issue/Submission Date
    1977-11-11
    2015-10-19
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      Divalproex Sodium

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2001-287 - Rev 01
      Valid
      Valproic acid
      2012-10-02
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2001-287 - Rev 01
      Status
      Valid
       
      Filing Details
      Valproic acid
      Issue/Submission Date
      2012-10-02
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        Polyvinyl Alcohol API

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        USDMF

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        CEP/COS

        Found CEP/COS

        R0-CEP 2022-281 - Rev 01
        Valid
        Poly(vinyl alcohol), Viscosity 42.5...
        2023-06-21
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        R0-CEP 2022-281 - Rev 01
        Status
        Valid
         
        Filing Details
        Poly(vinyl alcohol), Viscosity 42.5...
        Issue/Submission Date
        2023-06-21
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          Polyvinyl Alcohol API

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          USDMF

          Close USDMF

          CEP/COS

          Found CEP/COS

          R1-CEP 2013-209 - Rev 00
          Valid
          Poly(vinyl alcohol), Viscosity 5.1 ...
          2021-09-28
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 2013-209 - Rev 00
          Status
          Valid
           
          Filing Details
          Poly(vinyl alcohol), Viscosity 5.1 ...
          Issue/Submission Date
          2021-09-28
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          Ursodeoxycholic Acid

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          USDMF

          Found USDMF

          3312
          Active
          URSODEOXYCHOLIC ACID
          1978-08-09
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          3312
          Status
          Active
          Fees Unpaid
          N/A
           
          Filing Details
          URSODEOXYCHOLIC ACID
          Issue/Submission Date
          1978-08-09
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          Ebokaruseto

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          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          229MF10027
          Ebokaruseto at 3-2-10 Doshomachi, C...
          2017-02-08
          Written Confirmation

          Close WC

          Application Number
          229MF10027
          Status
           
          Filing Details
          Ebokaruseto at 3-2-10 Doshomachi, C...
          Issue/Submission Date
          2017-02-08
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          1,2,3,4-Tetrahydroisoquinoline-3-Carboxylic Acid

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          USDMF

          Caution USDMF

          7593
          Inactive
          BENZYL S-1,2,3,4-TETRAHYDROISOQUINO...
          1988-07-13
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          7593
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          BENZYL S-1,2,3,4-TETRAHYDROISOQUINO...
          Issue/Submission Date
          1988-07-13
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            2-Butyl-1H-Imidazole-4-Carbaldehyde

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            USDMF

            Caution USDMF

            13191
            Inactive
            2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDE...
            1998-09-18
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            13191
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDE...
            Issue/Submission Date
            1998-09-18
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