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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Quimica Sintetica S.A

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    QUIMICA SINTETICA S.A

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    Quimica Sintetica S.A.
    Spain_new Flag
    Country
    Country
    Spain
    Address
    Address
    Calle de Dulcinea, 0, 28805 Alcalá de Henares, Madrid
    Telephone
    Telephone
    +34 91 889 05 77
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.chemogroup.com/
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    Omeprazole

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    USDMF

    Found USDMF

    12605
    Active
    OMEPRAZOLE
    1997-07-23
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-093 - Rev 08
    Valid
    Omeprazole
    2019-02-04
    Japanese DMF

    Found JDMF

    218MF10191
    Omeprazole at Calle Dulcinea, s/n 2...
    2006-02-08
    Written Confirmation

    Close WC

    Application Number
    12605
    R1-CEP 1999-093 - Rev 08
    218MF10191
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Omeprazole at Calle Dulcinea, s/n 2...
    Issue/Submission Date
    1997-07-23
    2019-02-04
    2006-02-08
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    Ciprofloxacin Hydrochloride

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    USDMF

    Caution USDMF

    8517
    Inactive
    CIPROFLOXACIN HYDROCHLORIDE
    1990-04-05
    CEP/COS

    Found CEP/COS

    CEP 1999-096 - Rev 08
    Valid
    Ciprofloxacin Hydrochloride
    2024-02-16
    Japanese DMF

    Found JDMF

    217MF11306
    Ciprofloxacin hydrochloride at Call...
    2005-12-22
    Written Confirmation

    Close WC

    Application Number
    8517
    CEP 1999-096 - Rev 08
    217MF11306
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE
    Ciprofloxacin Hydrochloride
    Ciprofloxacin hydrochloride at Call...
    Issue/Submission Date
    1990-04-05
    2024-02-16
    2005-12-22
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    Lansoprazole

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    USDMF

    Caution USDMF

    17329
    Inactive
    LANZOPRAZOLE
    2004-04-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-123 - Rev 01
    Valid
    Lansoprazole, Micronised
    2021-07-23
    Japanese DMF

    Found JDMF

    220MF10029
    Lansoprazole at Calle Dulcinea, s/n...
    2008-01-23
    Written Confirmation

    Close WC

    Application Number
    17329
    R1-CEP 2015-123 - Rev 01
    220MF10029
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LANZOPRAZOLE
    Lansoprazole, Micronised
    Lansoprazole at Calle Dulcinea, s/n...
    Issue/Submission Date
    2004-04-27
    2021-07-23
    2008-01-23
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    Aciclovir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8584
    Active
    ACYCLOVIR
    1990-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-126 - Rev 03
    Valid
    Aciclovir
    2017-04-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8584
    R1-CEP 1998-126 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACYCLOVIR
    Aciclovir
    Issue/Submission Date
    1990-05-25
    2017-04-27
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    Ciprofloxacin

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    USDMF

    Found USDMF

    15913
    Active
    CIPROFLOXACIN
    2002-03-20
    CEP/COS

    Found CEP/COS

    CEP 2004-199 - Rev 07
    Valid
    Ciprofloxacin
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15913
    CEP 2004-199 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CIPROFLOXACIN
    Ciprofloxacin
    Issue/Submission Date
    2002-03-20
    2023-12-06
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    Famotidine

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    USDMF

    Found USDMF

    13036
    Active
    FAMOTIDINE
    1998-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10922
    Famotidine at Calle Dulcinea, s/n 2...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13036
    218MF10922
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FAMOTIDINE
    Famotidine at Calle Dulcinea, s/n 2...
    Issue/Submission Date
    1998-06-17
    2006-11-21
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    Guanfacine

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    USDMF

    Found USDMF

    8661
    Active
    GUANFACINE HYDROCHLORIDE
    1990-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10293
    Guanfacine hydrochloride at Calle D...
    2015-12-24
    Written Confirmation

    Close WC

    Application Number
    8661
    227MF10293
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GUANFACINE HYDROCHLORIDE
    Guanfacine hydrochloride at Calle D...
    Issue/Submission Date
    1990-07-12
    2015-12-24
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    Indapamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    9064
    Active
    INDAPAMIDE
    1991-03-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-159 - Rev 00
    Valid
    Indapamide
    2023-06-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9064
    R0-CEP 2021-159 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    INDAPAMIDE
    Indapamide
    Issue/Submission Date
    1991-03-25
    2023-06-19
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    Itraconazole

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    USDMF

    Found USDMF

    13012
    Active
    ITRACONAZOLE
    1998-05-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-006 - Rev 00
    Valid
    Itraconazole, Process II
    2021-04-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13012
    R1-CEP 2016-006 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ITRACONAZOLE
    Itraconazole, Process II
    Issue/Submission Date
    1998-05-28
    2021-04-16
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    Lansoprazole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-361 - Rev 02
    Valid
    Lansoprazole, GP2
    2020-06-24
    Japanese DMF

    Found JDMF

    230MF10154
    Lansoprazole at Calle Dulcinea, s/n...
    2018-11-14
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-361 - Rev 02
    230MF10154
    Status
    Valid
     
    Filing Details
    Lansoprazole, GP2
    Lansoprazole at Calle Dulcinea, s/n...
    Issue/Submission Date
    2020-06-24
    2018-11-14
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    Miconazole Nitrate

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    USDMF

    Found USDMF

    8205
    Active
    MICONAZOLE NITRATE
    1989-09-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-052 - Rev 00
    Valid
    Miconazole nitrate, Micronised
    2021-08-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8205
    R0-CEP 2020-052 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MICONAZOLE NITRATE
    Miconazole nitrate, Micronised
    Issue/Submission Date
    1989-09-06
    2021-08-10
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    Ofloxacin

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    USDMF

    Found USDMF

    14767
    Active
    OFLOXACIN
    2000-03-08
    CEP/COS

    Found CEP/COS

    CEP 2000-134 - Rev 07
    Valid
    Ofloxacin
    2023-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14767
    CEP 2000-134 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OFLOXACIN
    Ofloxacin
    Issue/Submission Date
    2000-03-08
    2023-10-11
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    Pantoprazole Sodium

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    USDMF

    Found USDMF

    17848
    Active
    PANTOPRAZOLE SODIUM
    2004-11-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-108 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate
    2021-05-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17848
    R1-CEP 2015-108 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2004-11-17
    2021-05-26
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    Rabeprazole

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-303 - Rev 00
    Valid
    Rabeprazole sodium hydrate
    2023-01-16
    Japanese DMF

    Found JDMF

    226MF10127
    Rabeprazole sodium at Calle Dulcine...
    2014-06-26
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-303 - Rev 00
    226MF10127
    Status
    Valid
     
    Filing Details
    Rabeprazole sodium hydrate
    Rabeprazole sodium at Calle Dulcine...
    Issue/Submission Date
    2023-01-16
    2014-06-26
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    Rabeprazole

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-173 - Rev 03
    Valid
    Rabeprazole sodium hydrate, Form Y
    2022-09-06
    Japanese DMF

    Found JDMF

    226MF10118
    Rabeprazole sodium at Calle Dulcine...
    2014-06-18
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-173 - Rev 03
    226MF10118
    Status
    Valid
     
    Filing Details
    Rabeprazole sodium hydrate, Form Y
    Rabeprazole sodium at Calle Dulcine...
    Issue/Submission Date
    2022-09-06
    2014-06-18
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    Sumatriptan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15376
    Active
    SUMATRIPTAN SUCCINATE
    2001-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-089 - Rev 01
    Valid
    Sumatriptan succinate
    2020-05-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15376
    R1-CEP 2001-089 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SUMATRIPTAN SUCCINATE
    Sumatriptan succinate
    Issue/Submission Date
    2001-04-05
    2020-05-27
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    Terbinafine Hydrochloride

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    USDMF

    Found USDMF

    17914
    Active
    TERBINAFINE HYDROCHLORIDE
    2004-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-269 - Rev 01
    Valid
    Terbinafine hydrochloride
    2020-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17914
    R1-CEP 2012-269 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TERBINAFINE HYDROCHLORIDE
    Terbinafine hydrochloride
    Issue/Submission Date
    2004-12-14
    2020-05-14
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    Famotidine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9084
    Inactive
    FAMOTIDINE
    1991-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10091
    Famotidine at Calle Dulcinea, s/n 2...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    9084
    227MF10091
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FAMOTIDINE
    Famotidine at Calle Dulcinea, s/n 2...
    Issue/Submission Date
    1991-03-25
    2015-03-12
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    Itraconazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    14507
    Inactive
    ITRACONAZOLE
    1999-11-09
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-139 - Rev 03
    Valid
    Itraconazole
    2016-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14507
    R1-CEP 1999-139 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ITRACONAZOLE
    Itraconazole
    Issue/Submission Date
    1999-11-09
    2016-12-09
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    Loratadine

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    USDMF

    Caution USDMF

    9830
    Inactive
    LORATADINE
    1992-07-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-172 - Rev 02
    Valid
    Loratadine, Micronised
    2021-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9830
    R1-CEP 2008-172 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LORATADINE
    Loratadine, Micronised
    Issue/Submission Date
    1992-07-22
    2021-03-04
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    Ranitidine Hydrochloride

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    USDMF

    Caution USDMF

    8494
    Inactive
    RANITIDINE HYDROCHLORIDE
    1990-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10189
    Ranitidine hydrochloride at Calle D...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    8494
    226MF10189
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RANITIDINE HYDROCHLORIDE
    Ranitidine hydrochloride at Calle D...
    Issue/Submission Date
    1990-03-27
    2014-09-30
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    Apremilast

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32119
    Active
    APREMILAST
    2017-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32119
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2017-10-10
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    Apremilast

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    USDMF

    Found USDMF

    34915
    Active
    APREMILAST (PROCESS II)
    2020-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34915
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREMILAST (PROCESS II)
    Issue/Submission Date
    2020-06-17
    ASK
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    Benznidazole

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    USDMF

    Found USDMF

    30195
    Active
    BENZNIDAZOLE
    2016-06-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30195
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BENZNIDAZOLE
    Issue/Submission Date
    2016-06-27
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    Candesartan Cilexetil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-228 - Rev 02
    Valid
    Candesartan cilexetil
    2020-06-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-228 - Rev 02
    Status
    Valid
     
    Filing Details
    Candesartan cilexetil
    Issue/Submission Date
    2020-06-11
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    Captopril

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    USDMF

    Found USDMF

    8460
    Active
    CAPTOPRIL
    1990-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8460
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CAPTOPRIL
    Issue/Submission Date
    1990-03-05
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    Celecoxib

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-160 - Rev 00
    Valid
    Celecoxib
    2021-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-160 - Rev 00
    Status
    Valid
     
    Filing Details
    Celecoxib
    Issue/Submission Date
    2021-11-17
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    Chloramphenicol

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    USDMF

    Found USDMF

    8935
    Active
    CHLORAMPHENICOL
    1990-11-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8935
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLORAMPHENICOL
    Issue/Submission Date
    1990-11-21
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    Ciprofloxacin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-219 - Rev 02
    Valid
    Ciprofloxacin, Process II
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-219 - Rev 02
    Status
    Valid
     
    Filing Details
    Ciprofloxacin, Process II
    Issue/Submission Date
    2023-12-06
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    Ciprofloxacin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11966
    Active
    CIPROFLOXACIN HYDROCHLORIDE
    1996-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11966
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE
    Issue/Submission Date
    1996-02-21
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    Droxidopa

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32264
    Active
    DROXIDOPA
    2017-11-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32264
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DROXIDOPA
    Issue/Submission Date
    2017-11-24
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    Edaravone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34776
    Active
    EDARAVONE
    2020-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34776
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EDARAVONE
    Issue/Submission Date
    2020-05-12
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    Eltrombopag

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    USDMF

    Found USDMF

    38254
    Active
    ELTROMBOPAG OLAMINE
    2023-05-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38254
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ELTROMBOPAG OLAMINE
    Issue/Submission Date
    2023-05-02
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    Fluconazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8975
    Active
    FLUCONAZOLE
    1991-02-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8975
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUCONAZOLE
    Issue/Submission Date
    1991-02-01
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    Fluoxetine Hydrochloride

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    USDMF

    Found USDMF

    12291
    Active
    FLUOXETINE HYDROCHLORIDE
    1996-12-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12291
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUOXETINE HYDROCHLORIDE
    Issue/Submission Date
    1996-12-18
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    Fosfomycin

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    USDMF

    Found USDMF

    33294
    Active
    FOSFOMYCIN TROMETHAMINE
    2018-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33294
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FOSFOMYCIN TROMETHAMINE
    Issue/Submission Date
    2018-11-02
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    Ketoconazole

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    USDMF

    Found USDMF

    12023
    Active
    KETOCONAZOLE
    1996-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12023
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    KETOCONAZOLE
    Issue/Submission Date
    1996-06-25
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    Ketorolac Trometamol

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    USDMF

    Found USDMF

    11980
    Active
    KETOROLAC TROMETHAMINE
    1996-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11980
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    KETOROLAC TROMETHAMINE
    Issue/Submission Date
    1996-05-24
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    Levofloxacin Hemihydrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-284 - Rev 01
    Valid
    Levofloxacin hemihydrate, Process I...
    2023-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-284 - Rev 01
    Status
    Valid
     
    Filing Details
    Levofloxacin hemihydrate, Process I...
    Issue/Submission Date
    2023-11-23
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    Loratadine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11803
    Active
    LORATADINE
    1995-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11803
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LORATADINE
    Issue/Submission Date
    1995-12-19
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10194
    Losartan potassium at Calle Dulcine...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    226MF10194
    Status
     
    Filing Details
    Losartan potassium at Calle Dulcine...
    Issue/Submission Date
    2014-09-30
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18984
    Active
    MELOXICAM
    2005-11-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18984
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELOXICAM
    Issue/Submission Date
    2005-11-24
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    Milnacipran HCl

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    USDMF

    Found USDMF

    31347
    Active
    LEVOMILNACIPRAN HYDROCHLORIDE
    2017-02-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31347
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LEVOMILNACIPRAN HYDROCHLORIDE
    Issue/Submission Date
    2017-02-17
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    Posaconazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35440
    Active
    POSACONAZOLE
    2020-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35440
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE
    Issue/Submission Date
    2020-12-22
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    Praziquantel

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-137 - Rev 00
    Valid
    Praziquantel
    2020-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-137 - Rev 00
    Status
    Valid
     
    Filing Details
    Praziquantel
    Issue/Submission Date
    2020-08-19
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    Rivaroxaban

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-405 - Rev 00
    Valid
    Rivaroxaban
    2021-07-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-405 - Rev 00
    Status
    Valid
     
    Filing Details
    Rivaroxaban
    Issue/Submission Date
    2021-07-30
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    Tamsulosin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-004 - Rev 03
    Valid
    Tamsulosin hydrochloride
    2023-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-004 - Rev 03
    Status
    Valid
     
    Filing Details
    Tamsulosin hydrochloride
    Issue/Submission Date
    2023-07-28
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    Terconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14622
    Active
    TERCONAZOLE
    1999-12-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14622
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TERCONAZOLE
    Issue/Submission Date
    1999-12-10
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    Tianeptine Sodium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-260 - Rev 00
    Valid
    Tianeptine sodium
    2019-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-260 - Rev 00
    Status
    Valid
     
    Filing Details
    Tianeptine sodium
    Issue/Submission Date
    2019-08-09
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-131 - Rev 00
    Valid
    Venlafaxine hydrochloride, Process ...
    2021-06-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-131 - Rev 00
    Status
    Valid
     
    Filing Details
    Venlafaxine hydrochloride, Process ...
    Issue/Submission Date
    2021-06-01
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