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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Esteve Quimica

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    Esteve Quimica
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    Spain
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    Passeig de la Zona Franca, 109, 4º Planta, 08038 Barcelona
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    +34 93 446 60 00
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    • FDA
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    Amlodipine Besylate

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    USDMF

    Caution USDMF

    15127
    Inactive
    AMLODIPINE BESILATE
    2000-11-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-073 - Rev 02
    Valid
    Amlodipine besilate
    2020-10-28
    Japanese DMF

    Found JDMF

    220MF10248
    Amlodipine besylate at Torre Esteve...
    2008-12-11
    Written Confirmation

    Close WC

    Application Number
    15127
    R1-CEP 2008-073 - Rev 02
    220MF10248
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMLODIPINE BESILATE
    Amlodipine besilate
    Amlodipine besylate at Torre Esteve...
    Issue/Submission Date
    2000-11-02
    2020-10-28
    2008-12-11
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    Omeprazole

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    USDMF

    Caution USDMF

    11017
    Inactive
    OMEPRAZOLE
    1994-08-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-145 - Rev 10
    Valid
    Omeprazole, Micronised and sieved g...
    2022-03-16
    Japanese DMF

    Found JDMF

    218MF10605
    Omeprazole at Torre Esteve, Pg. de ...
    2006-07-03
    Written Confirmation

    Close WC

    Application Number
    11017
    R1-CEP 1998-145 - Rev 10
    218MF10605
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole, Micronised and sieved g...
    Omeprazole at Torre Esteve, Pg. de ...
    Issue/Submission Date
    1994-08-02
    2022-03-16
    2006-07-03
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    • FDA
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    22427
    Active
    AZELASTINE HYDROCHLORIDE
    2009-01-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-010 - Rev 03
    Valid
    Azelastine hydrochloride
    2020-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22427
    R1-CEP 2010-010 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZELASTINE HYDROCHLORIDE
    Azelastine hydrochloride
    Issue/Submission Date
    2009-01-20
    2020-08-17
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    Diclofenac Sodium

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    USDMF

    Found USDMF

    9115
    Active
    DICLOFENAC SODIUM
    1991-04-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-133 - Rev 07
    Valid
    Diclofenac sodium
    2020-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9115
    R1-CEP 2000-133 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DICLOFENAC SODIUM
    Diclofenac sodium
    Issue/Submission Date
    1991-04-22
    2020-06-09
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    Duloxetine

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    USDMF

    Found USDMF

    24659
    Active
    DULOXETINE HYDROCHLORIDE
    2011-02-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-016 - Rev 02
    Valid
    Duloxetine hydrochloride
    2021-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24659
    R1-CEP 2013-016 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DULOXETINE HYDROCHLORIDE
    Duloxetine hydrochloride
    Issue/Submission Date
    2011-02-18
    2021-07-26
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    Omeprazole

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    USDMF

    Found USDMF

    11794
    Active
    OMEPRAZOLE
    1995-12-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-022 - Rev 04
    Valid
    Omeprazole
    2020-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11794
    R1-CEP 1996-022 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Issue/Submission Date
    1995-12-21
    2020-10-28
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    Riluzole

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    USDMF

    Found USDMF

    24693
    Active
    RILUZOLE
    2011-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10021
    Riluzole at Torre Esteve, Pg. de la...
    2012-02-01
    Written Confirmation

    Close WC

    Application Number
    24693
    224MF10021
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RILUZOLE
    Riluzole at Torre Esteve, Pg. de la...
    Issue/Submission Date
    2011-02-28
    2012-02-01
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    Felodipine

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    USDMF

    Caution USDMF

    12248
    Inactive
    FELODIPINE
    1996-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-090 - Rev 05
    Valid
    Felodipine
    2019-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12248
    R1-CEP 1996-090 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FELODIPINE
    Felodipine
    Issue/Submission Date
    1996-12-04
    2019-02-15
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    • FDA
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    Lansoprazole

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    USDMF

    Found USDMF

    19310
    Active
    LANSOPRAZOLE
    2006-03-09
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-331 - Rev 01
    Withdrawn by Holder
    Lansoprazole, Micronised
    2018-08-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19310
    R1-CEP 2007-331 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    LANSOPRAZOLE
    Lansoprazole, Micronised
    Issue/Submission Date
    2006-03-09
    2018-08-13
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    Levetiracetam

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    USDMF

    Caution USDMF

    17327
    Inactive
    LEVETIRACETAM
    2004-04-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-042 - Rev 05
    Valid
    Levetiracetam, Code product 2577
    2021-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17327
    R1-CEP 2011-042 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LEVETIRACETAM
    Levetiracetam, Code product 2577
    Issue/Submission Date
    2004-04-26
    2021-06-15
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    Meloxicam

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    USDMF

    Caution USDMF

    16686
    Inactive
    MELOXICAM
    2003-07-08
    CEP/COS

    Found CEP/COS

    CEP 2011-037 - Rev 02
    Valid
    Meloxicam, Powder and milled grade
    2024-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16686
    CEP 2011-037 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MELOXICAM
    Meloxicam, Powder and milled grade
    Issue/Submission Date
    2003-07-08
    2024-01-24
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      Bosentan Hydrate

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      USDMF

      Close USDMF

      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      227MF10082
      Bosentan hydrate at Linhai Rd. , Yu...
      2015-03-12
      Written Confirmation

      Close WC

      Application Number
      227MF10082
      Status
       
      Filing Details
      Bosentan hydrate at Linhai Rd. , Yu...
      Issue/Submission Date
      2015-03-12
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      Calcium

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 1997-069 - Rev 08
      Valid
      Calcium dobesilate monohydrate
      2018-08-09
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 1997-069 - Rev 08
      Status
      Valid
       
      Filing Details
      Calcium dobesilate monohydrate
      Issue/Submission Date
      2018-08-09
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      Celecoxib

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      USDMF

      Found USDMF

      33396
      Active
      CELECOXIB-TRAMADOL, CO CRYSTAL
      2019-02-04
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      33396
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      CELECOXIB-TRAMADOL, CO CRYSTAL
      Issue/Submission Date
      2019-02-04
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      Clindamycin Hydrochloride

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2000-041 - Rev 09
      Valid
      Clindamycin hydrochloride
      2022-03-08
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2000-041 - Rev 09
      Status
      Valid
       
      Filing Details
      Clindamycin hydrochloride
      Issue/Submission Date
      2022-03-08
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      Cyclopentolate Hydrochloride

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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2016-078 - Rev 00
      Valid
      Cyclopentolate hydrochloride
      2022-10-19
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2016-078 - Rev 00
      Status
      Valid
       
      Filing Details
      Cyclopentolate hydrochloride
      Issue/Submission Date
      2022-10-19
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      Diclofenac Sodium

      PDF Supplier PDF
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      USDMF

      Caution USDMF

      23200
      Inactive
      DICLOFENAC SODIUM INJECTABLE GRADE/...
      2009-10-21
      CEP/COS

      Caution CEP/COS

      R1-CEP 2009-389 - Rev 01
      Withdrawn by Holder
      Diclofenac sodium, Product code: 25...
      2017-07-20
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      23200
      R1-CEP 2009-389 - Rev 01
      Status
      Inactive
      Fees Paid
      N/A
      Withdrawn by Holder
       
      Filing Details
      DICLOFENAC SODIUM INJECTABLE GRADE/...
      Diclofenac sodium, Product code: 25...
      Issue/Submission Date
      2009-10-21
      2017-07-20
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      Enalapril Maleate

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      USDMF

      Caution USDMF

      11866
      Inactive
      ENALAPRIL MALEATE
      1996-02-27
      CEP/COS

      Caution CEP/COS

      R1-CEP 2000-258 - Rev 04
      Withdrawn by Holder
      Enalapril maleate
      2020-10-28
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      11866
      R1-CEP 2000-258 - Rev 04
      Status
      Inactive
      Fees Paid
      N/A
      Withdrawn by Holder
       
      Filing Details
      ENALAPRIL MALEATE
      Enalapril maleate
      Issue/Submission Date
      1996-02-27
      2020-10-28
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      Esomeprazole Sodium

      PDF Supplier PDF
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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R0-CEP 2018-256 - Rev 03
      Valid
      Esomeprazole sodium
      2022-04-14
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R0-CEP 2018-256 - Rev 03
      Status
      Valid
       
      Filing Details
      Esomeprazole sodium
      Issue/Submission Date
      2022-04-14
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      Ethamsylate

      PDF Supplier PDF
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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 1997-070 - Rev 08
      Valid
      Etamsylate, Code 0122-P54 - Code 01...
      2019-11-22
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 1997-070 - Rev 08
      Status
      Valid
       
      Filing Details
      Etamsylate, Code 0122-P54 - Code 01...
      Issue/Submission Date
      2019-11-22
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      Etofenamate

      PDF Supplier PDF
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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 2012-114 - Rev 02
      Valid
      Etofenamate
      2022-03-16
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2012-114 - Rev 02
      Status
      Valid
       
      Filing Details
      Etofenamate
      Issue/Submission Date
      2022-03-16
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      Fluoxetine Hydrochloride

      PDF Supplier PDF
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      USDMF

      Close USDMF

      CEP/COS

      Found CEP/COS

      R1-CEP 1999-071 - Rev 05
      Valid
      Fluoxetine hydrochloride
      2022-03-16
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      R1-CEP 1999-071 - Rev 05
      Status
      Valid
       
      Filing Details
      Fluoxetine hydrochloride
      Issue/Submission Date
      2022-03-16
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        Ibrutinib

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        USDMF

        Found USDMF

        31679
        Active
        IBRUTINIB
        2017-05-05
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        31679
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        IBRUTINIB
        Issue/Submission Date
        2017-05-05
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        Indomethacin

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        USDMF

        Caution USDMF

        4220
        Inactive
        INDOMETHACIN FOR HUMAN USE
        1981-03-18
        CEP/COS

        Caution CEP/COS

        R1-CEP 1997-006 - Rev 05
        Withdrawn by Holder
        Indometacin
        2020-10-28
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        4220
        R1-CEP 1997-006 - Rev 05
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        INDOMETHACIN FOR HUMAN USE
        Indometacin
        Issue/Submission Date
        1981-03-18
        2020-10-28
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        Levetiracetam

        PDF Supplier PDF
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        USDMF

        Found USDMF

        21837
        Active
        LEVETIRACETAM INJECTABLE GRADE/NON-...
        2008-07-28
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        21837
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        LEVETIRACETAM INJECTABLE GRADE/NON-...
        Issue/Submission Date
        2008-07-28
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        Lisinopril

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        USDMF

        Caution USDMF

        12968
        Inactive
        LISINOPRIL
        1998-04-24
        CEP/COS

        Caution CEP/COS

        R1-CEP 1999-024 - Rev 04
        Withdrawn by Holder
        Lisinopril dihydrate
        2015-06-30
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        12968
        R1-CEP 1999-024 - Rev 04
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        LISINOPRIL
        Lisinopril dihydrate
        Issue/Submission Date
        1998-04-24
        2015-06-30
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        Metoprolol Succinate

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        USDMF

        Caution USDMF

        10547
        Inactive
        METOPROLOL SUCCINATE
        1993-10-25
        CEP/COS

        Caution CEP/COS

        R1-CEP 2002-041 - Rev 03
        Withdrawn by Holder
        Metoprolol succinate
        2011-12-15
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        10547
        R1-CEP 2002-041 - Rev 03
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        METOPROLOL SUCCINATE
        Metoprolol succinate
        Issue/Submission Date
        1993-10-25
        2011-12-15
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        Metoprolol Tartrate

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        USDMF

        Caution USDMF

        8430
        Inactive
        METOPROLOL TATRATE
        1990-02-06
        CEP/COS

        Caution CEP/COS

        R1-CEP 2000-402 - Rev 02
        Withdrawn by Holder
        Metoprolol tartrate
        2012-02-13
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        8430
        R1-CEP 2000-402 - Rev 02
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        METOPROLOL TATRATE
        Metoprolol tartrate
        Issue/Submission Date
        1990-02-06
        2012-02-13
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        Omeprazole Sodium

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R1-CEP 2013-322 - Rev 02
        Valid
        Omeprazole sodium
        2022-03-30
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2013-322 - Rev 02
        Status
        Valid
         
        Filing Details
        Omeprazole sodium
        Issue/Submission Date
        2022-03-30
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        Pantoprazole Sodium

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        USDMF

        Caution USDMF

        16657
        Inactive
        PANTOPRAZOLE SODIUM
        2003-06-19
        CEP/COS

        Caution CEP/COS

        R1-CEP 2008-045 - Rev 02
        Withdrawn by Holder
        Pantoprazole sodium sesquihydrate
        2018-08-13
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        16657
        R1-CEP 2008-045 - Rev 02
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        PANTOPRAZOLE SODIUM
        Pantoprazole sodium sesquihydrate
        Issue/Submission Date
        2003-06-19
        2018-08-13
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        Pethidine Hydrochloride

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R1-CEP 2003-087 - Rev 03
        Valid
        Pethidine hydrochloride
        2022-03-16
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2003-087 - Rev 03
        Status
        Valid
         
        Filing Details
        Pethidine hydrochloride
        Issue/Submission Date
        2022-03-16
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        Pethidine Hydrochloride

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R1-CEP 2003-088 - Rev 03
        Valid
        Pethidine hydrochloride, For use in...
        2022-03-16
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2003-088 - Rev 03
        Status
        Valid
         
        Filing Details
        Pethidine hydrochloride, For use in...
        Issue/Submission Date
        2022-03-16
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        Piroxicam

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        USDMF

        Caution USDMF

        7697
        Inactive
        PIROXICAM
        1988-09-29
        CEP/COS

        Caution CEP/COS

        R1-CEP 1998-080 - Rev 02
        Withdrawn by Holder
        Piroxicam, powder or micronised
        2009-06-19
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        7697
        R1-CEP 1998-080 - Rev 02
        Status
        Inactive
        Fees Paid
        N/A
        Withdrawn by Holder
         
        Filing Details
        PIROXICAM
        Piroxicam, powder or micronised
        Issue/Submission Date
        1988-09-29
        2009-06-19
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        Ramipril

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        USDMF

        Caution USDMF

        16900
        Inactive
        RAMIPRIL
        2003-10-13
        CEP/COS

        Caution CEP/COS

        R0-CEP 2005-252 - Rev 03
        Expired
        Ramipril, powder, micronised
        2008-04-14
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        16900
        R0-CEP 2005-252 - Rev 03
        Status
        Inactive
        Fees Paid
        N/A
        Expired
         
        Filing Details
        RAMIPRIL
        Ramipril, powder, micronised
        Issue/Submission Date
        2003-10-13
        2008-04-14
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          Solifenacin Succinate

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          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          301MF10071
          Solifenacin Succinate at Linhai Rd....
          2019-10-01
          Written Confirmation

          Close WC

          Application Number
          301MF10071
          Status
           
          Filing Details
          Solifenacin Succinate at Linhai Rd....
          Issue/Submission Date
          2019-10-01
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          Astemizole

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          USDMF

          Caution USDMF

          11584
          Inactive
          ASTEMIZOLE
          1995-07-13
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          11584
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          ASTEMIZOLE
          Issue/Submission Date
          1995-07-13
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          Citalopram Hydrobromide

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          USDMF

          Caution USDMF

          17511
          Inactive
          CITALOPRAM HYDROBROMIDE
          2004-07-01
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          17511
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          CITALOPRAM HYDROBROMIDE
          Issue/Submission Date
          2004-07-01
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          Cizolirtine

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          USDMF

          Caution USDMF

          12820
          Inactive
          CIZOLIRTINE CITRATE
          1998-01-16
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          12820
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          CIZOLIRTINE CITRATE
          Issue/Submission Date
          1998-01-16
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          Diclofenac Potassium

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          USDMF

          Caution USDMF

          12021
          Inactive
          DICLOFENAC POTASSIUM
          1996-06-27
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          12021
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          DICLOFENAC POTASSIUM
          Issue/Submission Date
          1996-06-27
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          Enalaprilat

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          USDMF

          Caution USDMF

          12711
          Inactive
          ENALAPRILAT
          1997-10-21
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          12711
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          ENALAPRILAT
          Issue/Submission Date
          1997-10-21
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          Ketoconazole

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          USDMF

          Caution USDMF

          11579
          Inactive
          KETOCONAZOLE
          1995-07-13
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          11579
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          KETOCONAZOLE
          Issue/Submission Date
          1995-07-13
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          Lesopitron Dihydrochloride

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          USDMF

          Caution USDMF

          10717
          Inactive
          LESOPITRON DIHYDROCHLORIDE
          1994-02-07
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          10717
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          LESOPITRON DIHYDROCHLORIDE
          Issue/Submission Date
          1994-02-07
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          Lixivaptan

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          USDMF

          Caution USDMF

          12615
          Inactive
          VPA-985
          1997-07-29
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          12615
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          VPA-985
          Issue/Submission Date
          1997-07-29
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          Metoprolol Fumarate

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          USDMF

          Caution USDMF

          10546
          Inactive
          METOPROLOL FUMARATE
          1993-10-25
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          10546
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          METOPROLOL FUMARATE
          Issue/Submission Date
          1993-10-25
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          Moexipril

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          USDMF

          Caution USDMF

          15172
          Inactive
          MOEXIPRIL HYDROCHLORIDE
          2000-12-06
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          15172
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          MOEXIPRIL HYDROCHLORIDE
          Issue/Submission Date
          2000-12-06
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          Nabumetone

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          USDMF

          Caution USDMF

          11984
          Inactive
          NABUMETONE
          1996-06-03
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          11984
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          NABUMETONE
          Issue/Submission Date
          1996-06-03
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          Nefazodone Hydrochloride

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          USDMF

          Caution USDMF

          13856
          Inactive
          NEFAZODONE HYDRCHLORIDE
          1998-11-10
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          13856
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          NEFAZODONE HYDRCHLORIDE
          Issue/Submission Date
          1998-11-10
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          Quinapril

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          USDMF

          Caution USDMF

          12471
          Inactive
          QUINAPRIL HCL
          1997-04-14
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          12471
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          QUINAPRIL HCL
          Issue/Submission Date
          1997-04-14
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          Wy 50324

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          USDMF

          Caution USDMF

          15823
          Inactive
          ADATANSERIN HYDROCHLORIDE (CRUDE)
          2002-01-24
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          15823
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          ADATANSERIN HYDROCHLORIDE (CRUDE)
          Issue/Submission Date
          2002-01-24
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          Zidovudine

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          USDMF

          Caution USDMF

          10866
          Inactive
          AZT (ZIDOVUDINE)
          1994-04-07
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          10866
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          AZT (ZIDOVUDINE)
          Issue/Submission Date
          1994-04-07
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