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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Johnson & Johnson Innovative Medicine

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    Johnson & Johnson Innovative Medicine
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    1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
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    +1 8007755514
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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 Turnhoutseweg 30 B-2...
    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 Turnhoutseweg 30 B-2...
    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 Turnhoutseweg 30 B-23...
    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 Turnhoutseweg 30 B-23...
    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 Turnhoutseweg...
    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 Turnhoutseweg...
    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 2001-140 - Rev 05
    Valid
    Itraconazole, Method 2 (alternative...
    2016-01-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10725
    R1-CEP 2001-140 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ITRACONAZOLE (R051211) DRUG SUBSTAN...
    Itraconazole, Method 2 (alternative...
    Issue/Submission Date
    1994-02-18
    2016-01-22
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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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    Methylphenidate Hydrochloride

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    USDMF

    Found USDMF

    30510
    Active
    METHYLPHENIDATE HYDROCHLORIDE DRUG ...
    2016-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-219 - Rev 03
    Valid
    Methylphenidate hydrochloride
    2022-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30510
    R1-CEP 2009-219 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE DRUG ...
    Methylphenidate hydrochloride
    Issue/Submission Date
    2016-05-25
    2022-01-13
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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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    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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    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
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ALFENTANIL HYDROCHLORIDE
    Alfentanil hydrochloride hydrate
    Issue/Submission Date
    1995-02-03
    2016-09-23
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    Domperidone

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 1999-129 - Rev 02
    Withdrawn by Holder
    Domperidone
    2003-07-03
    Japanese DMF

    Found JDMF

    218MF10664
    Domperidone at Little Island Indust...
    2006-07-24
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 1999-129 - Rev 02
    218MF10664
    Status
    Withdrawn by Holder
     
    Filing Details
    Domperidone
    Domperidone at Little Island Indust...
    Issue/Submission Date
    2003-07-03
    2006-07-24
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    Galantamine Hydrobromide

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    USDMF

    Caution USDMF

    14425
    Inactive
    GALANTAMINE HYDROBROMIDE
    1999-09-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-248 - Rev 01
    Valid
    Galantamine hydrobromide, Produced ...
    2021-11-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14425
    R1-CEP 2012-248 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GALANTAMINE HYDROBROMIDE
    Galantamine hydrobromide, Produced ...
    Issue/Submission Date
    1999-09-29
    2021-11-19
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    Loperamide Hydrochloride

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    USDMF

    Caution USDMF

    10942
    Inactive
    LOPERAMIDE HYDROCHLORIDE
    1994-06-17
    CEP/COS

    Found CEP/COS

    R2-CEP 1994-020 - Rev 05
    Valid
    Loperamide hydrochloride
    2019-11-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10942
    R2-CEP 1994-020 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LOPERAMIDE HYDROCHLORIDE
    Loperamide hydrochloride
    Issue/Submission Date
    1994-06-17
    2019-11-19
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    Oxatomide

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    USDMF

    Caution USDMF

    5108
    Inactive
    OXATOMIDE-R 35443 AS PROCESSED IN T...
    1983-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10663
    Oxatomide at Little Island Industri...
    2006-07-24
    Written Confirmation

    Close WC

    Application Number
    5108
    218MF10663
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXATOMIDE-R 35443 AS PROCESSED IN T...
    Oxatomide at Little Island Industri...
    Issue/Submission Date
    1983-09-09
    2006-07-24
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    Sufentanil Citrate

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    USDMF

    Caution USDMF

    11327
    Inactive
    SUFENTANIL CITRATE
    1995-02-06
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-116 - Rev 07
    Valid
    Sufentanil citrate
    2022-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11327
    R1-CEP 1998-116 - Rev 07
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SUFENTANIL CITRATE
    Sufentanil citrate
    Issue/Submission Date
    1995-02-06
    2022-07-07
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    Abiraterone Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10100
    Abiraterone Acetate at Turnhoutsewe...
    2022-07-13
    Written Confirmation

    Close WC

    Application Number
    304MF10100
    Status
     
    Filing Details
    Abiraterone Acetate at Turnhoutsewe...
    Issue/Submission Date
    2022-07-13
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    Buprenorphine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10073
    Buprenorphine at Turnhoutseweg 30 B...
    2016-03-11
    Written Confirmation

    Close WC

    Application Number
    228MF10073
    Status
     
    Filing Details
    Buprenorphine at Turnhoutseweg 30 B...
    Issue/Submission Date
    2016-03-11
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    Cinnarizine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R2-CEP 1994-016 - Rev 03
    Valid
    Cinnarizine
    2011-10-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R2-CEP 1994-016 - Rev 03
    Status
    Valid
     
    Filing Details
    Cinnarizine
    Issue/Submission Date
    2011-10-27
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    Clazuril

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    USDMF

    Caution USDMF

    8054
    Inactive
    CLAZURIL TABLETS 2.5 MG (R 62690)
    1989-04-28
    CEP/COS

    Caution CEP/COS

    R0-CEP 2004-145 - Rev 00
    Expired
    Clazuril for veterinary use
    2006-05-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8054
    R0-CEP 2004-145 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    CLAZURIL TABLETS 2.5 MG (R 62690)
    Clazuril for veterinary use
    Issue/Submission Date
    1989-04-28
    2006-05-15
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    Darunavir

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    USDMF

    Found USDMF

    18825
    Active
    DARUNAVIR (R319064) DRUG SUBSTANCE
    2005-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18825
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DARUNAVIR (R319064) DRUG SUBSTANCE
    Issue/Submission Date
    2005-11-02
    ASK
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    Domperidone Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-084 - Rev 03
    Valid
    Domperidone maleate
    2022-09-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-084 - Rev 03
    Status
    Valid
     
    Filing Details
    Domperidone maleate
    Issue/Submission Date
    2022-09-05
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    Droperidol

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    USDMF

    Caution USDMF

    4890
    Inactive
    DROPERIDOL,CODE#R4749,MNFG IN BELGI...
    1983-03-31
    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-062 - Rev 02
    Withdrawn by Holder
    Droperidol
    2006-11-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4890
    R1-CEP 1997-062 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DROPERIDOL,CODE#R4749,MNFG IN BELGI...
    Droperidol
    Issue/Submission Date
    1983-03-31
    2006-11-15
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    Econazole Nitrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-072 - Rev 01
    Valid
    Econazole
    2020-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-072 - Rev 01
    Status
    Valid
     
    Filing Details
    Econazole
    Issue/Submission Date
    2020-08-04
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    Econazole Nitrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-126 - Rev 03
    Valid
    Econazole nitrate
    2020-09-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-126 - Rev 03
    Status
    Valid
     
    Filing Details
    Econazole nitrate
    Issue/Submission Date
    2020-09-03
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    Etomidate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10635
    Inactive
    ETOMIDATE
    1993-12-17
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-080 - Rev 03
    Withdrawn by Holder
    Etomidate
    2017-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10635
    R1-CEP 2002-080 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ETOMIDATE
    Etomidate
    Issue/Submission Date
    1993-12-17
    2017-11-03
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    Etravirine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20440
    Active
    ETRAVIRINE (R165335) DRUG SUBSTANCE
    2007-04-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20440
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ETRAVIRINE (R165335) DRUG SUBSTANCE
    Issue/Submission Date
    2007-04-18
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    Fentanyl

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-044 - Rev 03
    Valid
    Fentanyl
    2018-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-044 - Rev 03
    Status
    Valid
     
    Filing Details
    Fentanyl
    Issue/Submission Date
    2018-01-18
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    Fentanyl Citrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-045 - Rev 06
    Valid
    Fentanyl citrate
    2019-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-045 - Rev 06
    Status
    Valid
     
    Filing Details
    Fentanyl citrate
    Issue/Submission Date
    2019-06-17
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    Flubendazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-202 - Rev 00
    Valid
    Flubendazole
    2010-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-202 - Rev 00
    Status
    Valid
     
    Filing Details
    Flubendazole
    Issue/Submission Date
    2010-01-12
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    Flunarizine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-097 - Rev 04
    Valid
    Flunarizine dihydrochloride
    2023-07-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-097 - Rev 04
    Status
    Valid
     
    Filing Details
    Flunarizine dihydrochloride
    Issue/Submission Date
    2023-07-31
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    Galantamine Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15384
    Active
    GALANTAMINE HYDROBROMIDE DRUG SUBST...
    2001-05-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15384
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GALANTAMINE HYDROBROMIDE DRUG SUBST...
    Issue/Submission Date
    2001-05-08
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    Itraconazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    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
    R1-CEP 1999-092 - Rev 07
    Status
    Valid
     
    Filing Details
    Itraconazole, Method 1
    Issue/Submission Date
    2017-02-07
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    Ketoconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    10038
    Inactive
    INTERMEDIATES OF KETOCONAZOLE
    1993-01-15
    CEP/COS

    Caution CEP/COS

    R0-CEP 1997-105 - Rev 02
    Withdrawn by Holder
    Ketoconazole
    2003-08-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10038
    R0-CEP 1997-105 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    INTERMEDIATES OF KETOCONAZOLE
    Ketoconazole
    Issue/Submission Date
    1993-01-15
    2003-08-20
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    Methylphenidate Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30546
    Active
    METHYLPHENIDATE HYDROCHLORIDE DRUG ...
    2021-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30546
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE DRUG ...
    Issue/Submission Date
    2021-07-30
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    Nebivolol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15417
    Active
    NEBIVOLOL HYDROCHLORIDE(R067555) DR...
    2001-05-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15417
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NEBIVOLOL HYDROCHLORIDE(R067555) DR...
    Issue/Submission Date
    2001-05-07
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    Paliperidone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18915
    Active
    PALIPERIDONE (R076477) DRUG SUBSTAN...
    2005-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18915
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALIPERIDONE (R076477) DRUG SUBSTAN...
    Issue/Submission Date
    2005-11-29
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    Paliperidone Palmitate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20902
    Active
    PALIPERIDONE PALMITATE (R092670) DR...
    2007-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20902
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALIPERIDONE PALMITATE (R092670) DR...
    Issue/Submission Date
    2007-10-24
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    Pimozide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10872
    Inactive
    PIMOZIDE
    1994-04-18
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-010 - Rev 05
    Withdrawn by Holder
    Pimozide
    2018-01-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10872
    R1-CEP 1999-010 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PIMOZIDE
    Pimozide
    Issue/Submission Date
    1994-04-18
    2018-01-08
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    Rilpivirine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33713
    Active
    RILPIVIRINE DRUG SUBSTANCE
    2019-04-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33713
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RILPIVIRINE DRUG SUBSTANCE
    Issue/Submission Date
    2019-04-22
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    Rilpivirine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33715
    Active
    RILPIVIRINE EXTENDED RELEASE SUSPEN...
    2019-04-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33715
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RILPIVIRINE EXTENDED RELEASE SUSPEN...
    Issue/Submission Date
    2019-04-22
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    Rilpivirine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10184
    Rirupibirin hydrochloride at Turnho...
    2017-10-06
    Written Confirmation

    Close WC

    Application Number
    229MF10184
    Status
     
    Filing Details
    Rirupibirin hydrochloride at Turnho...
    Issue/Submission Date
    2017-10-06
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21592
    Active
    RIVAROXABAN 10 MG FILM COATED TABLE...
    2008-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21592
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVAROXABAN 10 MG FILM COATED TABLE...
    Issue/Submission Date
    2008-07-24
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    Terconazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    5925
    Inactive
    TERCONAZOLE (PRODUCT # R42470)
    1985-07-19
    CEP/COS

    Caution CEP/COS

    R0-CEP 2000-219 - Rev 02
    Withdrawn by Holder
    Terconazole
    2004-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5925
    R0-CEP 2000-219 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    TERCONAZOLE (PRODUCT # R42470)
    Terconazole
    Issue/Submission Date
    1985-07-19
    2004-11-16
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    Tipifarnib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17517
    Active
    TIPIFARNIB (R115777) DRUG SUBSTANCE
    2004-07-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17517
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TIPIFARNIB (R115777) DRUG SUBSTANCE
    Issue/Submission Date
    2004-07-14
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    INTERMEDIATE T000034

    PDF Supplier PDF
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    USDMF

    Found USDMF

    10751
    Active
    INTERMEDIATE T000034
    1994-03-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10751
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INTERMEDIATE T000034
    Issue/Submission Date
    1994-03-04
    ASK
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    INTERMEDIATE T000263

    PDF Supplier PDF
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    USDMF

    Found USDMF

    10947
    Active
    INTERMEDIATE T000263
    1994-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10947
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INTERMEDIATE T000263
    Issue/Submission Date
    1994-06-13
    ASK
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    Mebendazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10600
    Inactive
    MEBENDAZOLE POLYMORPH B DRUG SUBSTA...
    1993-12-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10600
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MEBENDAZOLE POLYMORPH B DRUG SUBSTA...
    Issue/Submission Date
    1993-12-07
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