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

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    Mitsubishi Tanabe Pharma
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    Yodoyabashi Square 2-6-18, Kitahama, Chuo-kuOSAKA-SHI, OSK 541-8505
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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

    Close CEP/COS

    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    Withdrawn by Holder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    Withdrawn by Holder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

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          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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            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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            Aspartic Acid API

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            USDMF

            Caution USDMF

            1272
            Inactive
            L-ASPARTIC ACID
            1968-12-27
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1272
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ASPARTIC ACID
            Issue/Submission Date
            1968-12-27
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            Cholebine

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            USDMF

            Caution USDMF

            15946
            Inactive
            MCI-196 DRUG SUBSTANCE
            2002-04-22
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            15946
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MCI-196 DRUG SUBSTANCE
            Issue/Submission Date
            2002-04-22
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            Coleneuramide

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            USDMF

            Caution USDMF

            16071
            Inactive
            MCC-257
            2002-07-30
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            16071
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MCC-257
            Issue/Submission Date
            2002-07-30
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            Diltiazem Hydrochloride

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            USDMF

            Caution USDMF

            10381
            Inactive
            DILTIAZEM HYDROCHLORIDE (PROCESS C)
            1993-07-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10381
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DILTIAZEM HYDROCHLORIDE (PROCESS C)
            Issue/Submission Date
            1993-07-09
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            Diltiazem Malate

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            USDMF

            Caution USDMF

            11077
            Inactive
            DILTIAZEM MALATE
            1994-09-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            11077
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DILTIAZEM MALATE
            Issue/Submission Date
            1994-09-09
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            Dl-Histidine Monohydrochloride Monohydrate

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            USDMF

            Caution USDMF

            1251
            Inactive
            L-HISTIDINE MONOHYDROCHLORIDE MONOH...
            1968-10-25
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1251
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-HISTIDINE MONOHYDROCHLORIDE MONOH...
            Issue/Submission Date
            1968-10-25
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            Dl-Phenylalanine

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            USDMF

            Caution USDMF

            1316
            Inactive
            DL-PHENYLALANINE
            1969-01-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1316
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DL-PHENYLALANINE
            Issue/Submission Date
            1969-01-23
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            Dl-Threonine

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            USDMF

            Caution USDMF

            1318
            Inactive
            DL-THREONINE
            1969-01-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1318
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DL-THREONINE
            Issue/Submission Date
            1969-01-23
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            Dl-Tryptophan

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            USDMF

            Caution USDMF

            1317
            Inactive
            DL-TRYPTOPHAN
            1969-01-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1317
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DL-TRYPTOPHAN
            Issue/Submission Date
            1969-01-23
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            DL-Valine API

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            USDMF

            Caution USDMF

            1315
            Inactive
            DL-VALINE
            1969-01-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1315
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DL-VALINE
            Issue/Submission Date
            1969-01-23
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            Glycine

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            USDMF

            Caution USDMF

            1899
            Inactive
            GLYCINE (AMINOACETIC ACID)
            1972-03-01
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1899
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            GLYCINE (AMINOACETIC ACID)
            Issue/Submission Date
            1972-03-01
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            Isoleucine

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            USDMF

            Caution USDMF

            1250
            Inactive
            L-ISOLEUCINE
            1968-10-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1250
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ISOLEUCINE
            Issue/Submission Date
            1968-10-23
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            L-Alanine API

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            USDMF

            Caution USDMF

            1804
            Inactive
            L-ALANINE
            1971-09-24
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1804
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ALANINE
            Issue/Submission Date
            1971-09-24
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            L-Alanine API

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            USDMF

            Caution USDMF

            10617
            Inactive
            L-ALANINE
            1993-10-08
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10617
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ALANINE
            Issue/Submission Date
            1993-10-08
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            L-Arginine

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            USDMF

            Caution USDMF

            1929
            Inactive
            L-ARGININE BASE
            1972-05-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1929
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ARGININE BASE
            Issue/Submission Date
            1972-05-09
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            L-Arginine Hydrochloride API

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            USDMF

            Caution USDMF

            1274
            Inactive
            L-ARGININE MONOHYDROCHLORIDE
            1968-12-31
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1274
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ARGININE MONOHYDROCHLORIDE
            Issue/Submission Date
            1968-12-31
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            L-Asparagine Monohydrate

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            USDMF

            Caution USDMF

            1932
            Inactive
            L-ASPARAGINE MONOHYDRATE
            1972-05-16
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1932
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-ASPARAGINE MONOHYDRATE
            Issue/Submission Date
            1972-05-16
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            L-Cysteine Hydrochloride

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            USDMF

            Caution USDMF

            1930
            Inactive
            L-CYSTEINE MONOHYDROCHLORIDE MONOHY...
            1972-05-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1930
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-CYSTEINE MONOHYDROCHLORIDE MONOHY...
            Issue/Submission Date
            1972-05-09
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            L-Glutamine

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            USDMF

            Caution USDMF

            1833
            Inactive
            L-GLUTAMINE
            1971-12-17
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1833
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-GLUTAMINE
            Issue/Submission Date
            1971-12-17
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            L-Histidine

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            USDMF

            Caution USDMF

            1931
            Inactive
            L-HISTIDINE BASE
            1972-05-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1931
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-HISTIDINE BASE
            Issue/Submission Date
            1972-05-09
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            L-Leucine API

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            USDMF

            Caution USDMF

            1275
            Inactive
            L-LEUCINE
            1968-12-31
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1275
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-LEUCINE
            Issue/Submission Date
            1968-12-31
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            L-Lysine Hydrochloride

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            USDMF

            Caution USDMF

            1835
            Inactive
            L-LYSINE MONOHYDROCHLORIDE
            1971-12-06
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1835
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-LYSINE MONOHYDROCHLORIDE
            Issue/Submission Date
            1971-12-06
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            L-Threonine

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            USDMF

            Caution USDMF

            1248
            Inactive
            L-THREONINE
            1968-10-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1248
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-THREONINE
            Issue/Submission Date
            1968-10-23
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            L-Threonine

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            USDMF

            Caution USDMF

            10061
            Inactive
            L-THREONINE
            1993-01-26
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10061
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-THREONINE
            Issue/Submission Date
            1993-01-26
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            L-Tyrosine API

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            USDMF

            Caution USDMF

            1928
            Inactive
            L-TYROSINE
            1972-05-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1928
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-TYROSINE
            Issue/Submission Date
            1972-05-09
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            L-Tyrosine Ethyl Ester Hydrochloride

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            USDMF

            Caution USDMF

            1831
            Inactive
            L - TYROSINE ETHYLESTER MONOHYDROCH...
            1971-12-17
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1831
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L - TYROSINE ETHYLESTER MONOHYDROCH...
            Issue/Submission Date
            1971-12-17
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            L-VALINE

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            USDMF

            Caution USDMF

            1253
            Inactive
            L-VALINE
            1968-10-25
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1253
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-VALINE
            Issue/Submission Date
            1968-10-25
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            Lysine

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            USDMF

            Caution USDMF

            10062
            Inactive
            L-LYSINE
            1993-01-26
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10062
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-LYSINE
            Issue/Submission Date
            1993-01-26
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            Lysine Acetate

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            USDMF

            Caution USDMF

            1937
            Inactive
            L-LYSINE ACETATE
            1972-05-15
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1937
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-LYSINE ACETATE
            Issue/Submission Date
            1972-05-15
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            Methionine

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            USDMF

            Caution USDMF

            1832
            Inactive
            DL - METHIONINE
            1971-12-17
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1832
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            DL - METHIONINE
            Issue/Submission Date
            1971-12-17
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            Netoglitazone

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            USDMF

            Caution USDMF

            13979
            Inactive
            MCC-555
            1999-02-17
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            13979
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MCC-555
            Issue/Submission Date
            1999-02-17
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            Osemozotan Hydrochloride

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            USDMF

            Caution USDMF

            14242
            Inactive
            MKC-242 BULK DRUG SUBSTANCE
            1999-06-29
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            14242
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MKC-242 BULK DRUG SUBSTANCE
            Issue/Submission Date
            1999-06-29
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            Phenylalanine

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            USDMF

            Caution USDMF

            1273
            Inactive
            L-PHENYLALANINE
            1968-12-27
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

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            Application Number
            1273
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-PHENYLALANINE
            Issue/Submission Date
            1968-12-27
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            Proline

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            USDMF

            Caution USDMF

            10063
            Inactive
            L-PROLINE
            1993-01-26
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10063
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-PROLINE
            Issue/Submission Date
            1993-01-26
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            Serine

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            USDMF

            Caution USDMF

            1806
            Inactive
            L-SERINE
            1971-09-20
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1806
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-SERINE
            Issue/Submission Date
            1971-09-20
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            Thiopental Sodium

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            USDMF

            Caution USDMF

            1776
            Inactive
            SODIUM THIOPENTAL INJECTION
            1971-08-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1776
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            SODIUM THIOPENTAL INJECTION
            Issue/Submission Date
            1971-08-09
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            Tryptophan

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            USDMF

            Caution USDMF

            1252
            Inactive
            L-TRYPTOPHAN
            1968-10-23
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            1252
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            L-TRYPTOPHAN
            Issue/Submission Date
            1968-10-23
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            HER.TIAZEPN

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            USDMF

            Caution USDMF

            10169
            Inactive
            HER.TIAZEPN
            1993-03-26
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            10169
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            HER.TIAZEPN
            Issue/Submission Date
            1993-03-26
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            MCC-135 (BULK DRUG SUBSTANCE)

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            USDMF

            Caution USDMF

            13070
            Inactive
            MCC-135 (BULK DRUG SUBSTANCE)
            1998-07-15
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            13070
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MCC-135 (BULK DRUG SUBSTANCE)
            Issue/Submission Date
            1998-07-15
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            MP-513 DRUG SUBSTANCE

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            USDMF

            Caution USDMF

            18743
            Inactive
            MP-513 DRUG SUBSTANCE
            2005-09-09
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            18743
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            MP-513 DRUG SUBSTANCE
            Issue/Submission Date
            2005-09-09
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            Y-39983 DRUG SUBSTANCE

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            USDMF

            Caution USDMF

            19451
            Inactive
            Y-39983 DRUG SUBSTANCE
            2006-05-22
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            19451
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            Y-39983 DRUG SUBSTANCE
            Issue/Submission Date
            2006-05-22
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