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

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    Janssen Pharmaceutical
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    Country
    U.S.A
    Address
    Address
    1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
    Telephone
    Telephone
    +1-800-775-5514.
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    enquiries@pharmacompass.com
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    https://www.janssen.com/us/
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    Domperidone

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    USDMF

    Caution USDMF

    5402
    Inactive
    DOMPERIDONE (RESEARCH CODE R-33812)
    1984-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-069 - Rev 10
    Valid
    Domperidone
    2019-10-22
    Japanese DMF

    Found JDMF

    218MF10687
    Domperidone at Turnhoutsweg 30 B-23...
    2006-08-11
    Written Confirmation

    Close WC

    Application Number
    5402
    R1-CEP 1996-069 - Rev 10
    218MF10687
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOMPERIDONE (RESEARCH CODE R-33812)
    Domperidone
    Domperidone at Turnhoutsweg 30 B-23...
    Issue/Submission Date
    1984-05-17
    2019-10-22
    2006-08-11
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    Levocabastine

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    USDMF

    Caution USDMF

    5847
    Inactive
    LEVOCABASTINE HCL.(BULK)
    1985-04-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-147 - Rev 03
    Valid
    Levocabastine hydrochloride
    2020-12-09
    Japanese DMF

    Found JDMF

    228MF10206
    Levocabastine hydrochloride at Turn...
    2016-11-02
    Written Confirmation

    Close WC

    Application Number
    5847
    R1-CEP 2002-147 - Rev 03
    228MF10206
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LEVOCABASTINE HCL.(BULK)
    Levocabastine hydrochloride
    Levocabastine hydrochloride at Turn...
    Issue/Submission Date
    1985-04-19
    2020-12-09
    2016-11-02
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    Miconazole

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    USDMF

    Caution USDMF

    10912
    Inactive
    MICONAZOLE DRUG SUBSTANCE
    1994-05-20
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-007 - Rev 03
    Valid
    Miconazole
    2014-11-14
    Japanese DMF

    Found JDMF

    219MF10165
    Miconazole at Turnhoutsweg 30 B-234...
    2007-05-21
    Written Confirmation

    Close WC

    Application Number
    10912
    R2-CEP 1995-007 - Rev 03
    219MF10165
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MICONAZOLE DRUG SUBSTANCE
    Miconazole
    Miconazole at Turnhoutsweg 30 B-234...
    Issue/Submission Date
    1994-05-20
    2014-11-14
    2007-05-21
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    Miconazole Nitrate

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    USDMF

    Caution USDMF

    10913
    Inactive
    MICONAZOLE NITRATE DRUG SUBSTANCE
    1994-05-20
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-008 - Rev 04
    Valid
    Miconazole nitrate
    2023-03-01
    Japanese DMF

    Found JDMF

    219MF10167
    Miconazole nitrate at Turnhoutsweg ...
    2007-05-21
    Written Confirmation

    Close WC

    Application Number
    10913
    R2-CEP 1995-008 - Rev 04
    219MF10167
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MICONAZOLE NITRATE DRUG SUBSTANCE
    Miconazole nitrate
    Miconazole nitrate at Turnhoutsweg ...
    Issue/Submission Date
    1994-05-20
    2023-03-01
    2007-05-21
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    Haloperidol

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    USDMF

    Found USDMF

    10946
    Active
    HALOPERIDOL (R001625) DRUG SUBSTANC...
    1994-06-13
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-076 - Rev 09
    Valid
    Haloperidol
    2014-06-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10946
    R1-CEP 1998-076 - Rev 09
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    HALOPERIDOL (R001625) DRUG SUBSTANC...
    Haloperidol
    Issue/Submission Date
    1994-06-13
    2014-06-05
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    Haloperidol Decanoate

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    USDMF

    Found USDMF

    10954
    Active
    HALOPERIDOL DECANOATE
    1994-06-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-187 - Rev 04
    Valid
    Haloperidol decanoate
    2014-06-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10954
    R1-CEP 2002-187 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    HALOPERIDOL DECANOATE
    Haloperidol decanoate
    Issue/Submission Date
    1994-06-23
    2014-06-12
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    Itraconazole

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    USDMF

    Found USDMF

    10725
    Active
    ITRACONAZOLE (R051211) DRUG SUBSTAN...
    1994-02-18
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-092 - Rev 07
    Valid
    Itraconazole Method 1
    2017-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10725
    R1-CEP 1999-092 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ITRACONAZOLE (R051211) DRUG SUBSTAN...
    Itraconazole Method 1
    Issue/Submission Date
    1994-02-18
    2017-02-07
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    Ketoconazole

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    USDMF

    Found USDMF

    10037
    Active
    KETOCONAZOLE DRUG SUBSTANCE
    1993-01-15
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-009 - Rev 04
    Valid
    Ketoconazole
    2021-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10037
    R2-CEP 1995-009 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    KETOCONAZOLE DRUG SUBSTANCE
    Ketoconazole
    Issue/Submission Date
    1993-01-15
    2021-03-08
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    Rilpivirine Hydrochloride

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    USDMF

    Found USDMF

    23824
    Active
    RILPIVIRINE HYDROCHLORIDE (R314585)...
    2010-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10183
    Rirupibirin hydrochloride at Little...
    2017-10-06
    Written Confirmation

    Close WC

    Application Number
    23824
    229MF10183
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RILPIVIRINE HYDROCHLORIDE (R314585)...
    Rirupibirin hydrochloride at Little...
    Issue/Submission Date
    2010-07-19
    2017-10-06
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    Risperidone

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    USDMF

    Found USDMF

    11438
    Active
    RISPERIDONE (R064766) DRUG SUBSTANC...
    1995-04-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-183 - Rev 05
    Valid
    Risperidone
    2017-01-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11438
    R1-CEP 2001-183 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RISPERIDONE (R064766) DRUG SUBSTANC...
    Risperidone
    Issue/Submission Date
    1995-04-11
    2017-01-10
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    • FDA
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    Topiramate

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    USDMF

    Found USDMF

    10919
    Active
    TOPIRAMATE DRUG SUBSTANCE
    1994-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10001
    Topiramate at 1440 Olympic Drive, A...
    2008-01-09
    Written Confirmation

    Close WC

    Application Number
    10919
    220MF10001
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TOPIRAMATE DRUG SUBSTANCE
    Topiramate at 1440 Olympic Drive, A...
    Issue/Submission Date
    1994-05-27
    2008-01-09
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    • FDA
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    Alfentanil Hydrochloride

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    USDMF

    Caution USDMF

    11337
    Inactive
    ALFENTANIL HYDROCHLORIDE
    1995-02-03
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-086 - Rev 03
    Valid
    Alfentanil hydrochloride hydrate
    2016-09-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11337
    R1-CEP 1997-086 - Rev 03