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

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    CHEMO
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    Country
    Country
    Spain
    Address
    Address
    Chemo Barcelona, Gran Via Carlos III, 98 7th floor 08028 Barcelona
    Telephone
    Telephone
    +34 93 330 62 12
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.chemogroup.com
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    • FDA
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    Desogestrel

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    USDMF

    Found USDMF

    15771
    Active
    DESOGESTREL
    2001-12-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-185 - Rev 00
    Valid
    Desogestrel
    2013-03-22
    Japanese DMF

    Found JDMF

    230MF10041
    Desogestrel at Via E. H. Grieg, 13,...
    2018-02-28
    Written Confirmation

    Close WC

    Application Number
    15771
    R1-CEP 2006-185 - Rev 00
    230MF10041
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DESOGESTREL
    Desogestrel
    Desogestrel at Via E. H. Grieg, 13,...
    Issue/Submission Date
    2001-12-17
    2013-03-22
    2018-02-28
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    Dienogest

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    USDMF

    Found USDMF

    23428
    Active
    DIENOGEST
    2010-01-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-333 - Rev 00
    Valid
    Dienogest
    2023-01-20
    Japanese DMF

    Found JDMF

    227MF10213
    Dienogest at Via E. H. Grieg, 13,21...
    2015-08-31
    Written Confirmation

    Close WC

    Application Number
    23428
    R1-CEP 2016-333 - Rev 00
    227MF10213
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIENOGEST
    Dienogest
    Dienogest at Via E. H. Grieg, 13,21...
    Issue/Submission Date
    2010-01-05
    2023-01-20
    2015-08-31
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    • FDA
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    Drospirenone

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    USDMF

    Found USDMF

    20676
    Active
    DROSPIRENONE USP
    2007-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-336 - Rev 00
    Valid
    Drospirenone, Fine Form
    2019-02-12
    Japanese DMF

    Found JDMF

    303MF10024
    Drospirenone at Via E. H. Grieg, 13...
    2021-02-01
    Written Confirmation

    Close WC

    Application Number
    20676
    R1-CEP 2013-336 - Rev 00
    303MF10024
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DROSPIRENONE USP
    Drospirenone, Fine Form
    Drospirenone at Via E. H. Grieg, 13...
    Issue/Submission Date
    2007-07-11
    2019-02-12
    2021-02-01
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    • FDA
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    Fulvestrant

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    USDMF

    Found USDMF

    29104
    Active
    FULVESTRANT USP
    2015-03-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-169 - Rev 00
    Valid
    Fulvestrant
    2022-04-19
    Japanese DMF

    Found JDMF

    303MF10021
    Fulvestrant at Via E. H. Grieg, 13,...
    2021-01-28
    Written Confirmation

    Close WC

    Application Number
    29104
    R1-CEP 2015-169 - Rev 00
    303MF10021
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FULVESTRANT USP
    Fulvestrant
    Fulvestrant at Via E. H. Grieg, 13,...
    Issue/Submission Date
    2015-03-09
    2022-04-19
    2021-01-28
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    • FDA
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    Levonorgestrel

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    USDMF

    Found USDMF

    16696
    Active
    LEVONORGESTREL USP
    2003-07-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-127 - Rev 02
    Valid
    Levonorgestrel
    2012-03-06
    Japanese DMF

    Found JDMF

    221MF10183
    Levonorgestrel at Via E. H. Grieg, ...
    2009-08-13
    Written Confirmation

    Close WC

    Application Number
    16696
    R1-CEP 2003-127 - Rev 02
    221MF10183
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVONORGESTREL USP
    Levonorgestrel
    Levonorgestrel at Via E. H. Grieg, ...
    Issue/Submission Date
    2003-07-07
    2012-03-06
    2009-08-13
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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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    • FDA
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    Zopiclone

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    USDMF

    Found USDMF

    14661
    Active
    ZOPICLONE
    2000-01-03
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-075 - Rev 04
    Valid
    Zopiclone
    2016-10-10
    Japanese DMF

    Found JDMF

    220MF10114
    ZOPICLONE at Via E. H. Grieg, 13,21...
    2008-04-21
    Written Confirmation

    Close WC

    Application Number
    14661
    R1-CEP 1997-075 - Rev 04
    220MF10114
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ZOPICLONE
    Zopiclone
    ZOPICLONE at Via E. H. Grieg, 13,21...
    Issue/Submission Date
    2000-01-03
    2016-10-10
    2008-04-21
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    • FDA
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    Budesonide

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    USDMF

    Caution USDMF

    15877
    Inactive
    BUDESONIDE
    2002-04-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-152 - Rev 04
    Valid
    Budesonide
    2012-03-16
    Japanese DMF

    Found JDMF

    229MF10129
    BUDESONIDE at Via E. H. Grieg, 13,2...
    2017-07-14
    Written Confirmation

    Close WC

    Application Number
    15877
    R1-CEP 2000-152 - Rev 04
    229MF10129
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BUDESONIDE
    Budesonide
    BUDESONIDE at Via E. H. Grieg, 13,2...
    Issue/Submission Date
    2002-04-03
    2012-03-16
    2017-07-14
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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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    • FDA
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    Formoterol Fumarate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    14154
    Inactive
    FORMOTEROL FUMARATE DIHYDRATE MICRO...
    1999-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-171 - Rev 03
    Valid
    Formoterol fumarate dihydrate
    2020-07-29
    Japanese DMF

    Found JDMF

    229MF10130
    FORMOTEROL FUMARATE DIHYDRATE at Vi...
    2017-07-14
    Written Confirmation

    Close WC

    Application Number
    14154
    R1-CEP 2005-171 - Rev 03
    229MF10130
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FORMOTEROL FUMARATE DIHYDRATE MICRO...
    Formoterol fumarate dihydrate
    FORMOTEROL FUMARATE DIHYDRATE at Vi...
    Issue/Submission Date
    1999-05-25
    2020-07-29
    2017-07-14
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    Lansoprazole

    PDF Supplier PDF
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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

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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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    • FDA
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    Bumetanide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24750
    Active
    BUMETANIDE
    2011-03-14
    CEP/COS

    Found CEP/COS

    CEP 2001-293 - Rev 06
    Valid
    Bumetanide
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24750
    CEP 2001-293 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUMETANIDE
    Bumetanide
    Issue/Submission Date
    2011-03-14
    2024-03-11
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    Ciprofloxacin

    PDF Supplier PDF
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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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    • FDA
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    Desogestrel

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    23652
    Active
    DESOGESTREL CN
    2010-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10125
    Desogestrel at Via E. H. Greig, 13,...
    2009-06-23
    Written Confirmation

    Close WC

    Application Number
    23652
    221MF10125
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DESOGESTREL CN
    Desogestrel at Via E. H. Greig, 13,...
    Issue/Submission Date
    2010-03-24
    2009-06-23
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    • FDA
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    Eplerenone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19715
    Active
    EPLERENONE
    2006-09-08
    CEP/COS

    Found CEP/COS

    CEP 2017-004 - Rev 03
    Valid
    Eplerenone
    2023-10-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19715
    CEP 2017-004 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    EPLERENONE
    Eplerenone
    Issue/Submission Date
    2006-09-08
    2023-10-18
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    • FDA
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    Ethinyl Estradiol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20297
    Active
    ETHINYLESTRADIOL USP
    2007-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-030 - Rev 00
    Valid
    Ethinylestradiol
    2019-10-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20297
    R1-CEP 2013-030 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ETHINYLESTRADIOL USP
    Ethinylestradiol
    Issue/Submission Date
    2007-02-23
    2019-10-07
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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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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28322
    Active
    FINGOLIMOD HYDROCHLORIDE (CODE 5099...
    2014-07-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-312 - Rev 00
    Valid
    Fingolimod hydrochloride
    2021-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28322
    R0-CEP 2020-312 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE (CODE 5099...
    Fingolimod hydrochloride
    Issue/Submission Date
    2014-07-08
    2021-10-28
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    Flecainide

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    USDMF

    Found USDMF

    10688
    Active
    FLECAINIDE ACETATE PROCESS I (CODE ...
    1994-01-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-055 - Rev 03
    Valid
    Flecainide acetate
    2022-04-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10688
    R1-CEP 2010-055 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLECAINIDE ACETATE PROCESS I (CODE ...
    Flecainide acetate
    Issue/Submission Date
    1994-01-24
    2022-04-01
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    • FDA
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    23427
    Active
    FLUTICASONE PROPIONATE USP
    2010-01-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-024 - Rev 00
    Valid
    Fluticasone propionate
    2019-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23427
    R1-CEP 2012-024 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE USP
    Fluticasone propionate
    Issue/Submission Date
    2010-01-05
    2019-02-11
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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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    • FDA
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    Indapamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21663
    Active
    INDAPAMIDE
    2008-05-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-140 - Rev 01
    Valid
    Indapamide
    2021-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21663
    R1-CEP 2008-140 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    INDAPAMIDE
    Indapamide
    Issue/Submission Date
    2008-05-20
    2021-03-29
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    Indapamide

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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

    PDF Supplier PDF
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    See Less

    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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    Latanoprost

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    USDMF

    Found USDMF

    25931
    Active
    LATANOPROST
    2012-04-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-071 - Rev 00
    Valid
    Latanoprost
    2023-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25931
    R0-CEP 2022-071 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LATANOPROST
    Latanoprost
    Issue/Submission Date
    2012-04-02
    2023-03-17
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    Leflunomide

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    USDMF

    Found USDMF

    32988
    Active
    LEFLUNOMIDE
    2018-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-252 - Rev 01
    Valid
    Leflunomide
    2022-10-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32988
    R0-CEP 2018-252 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEFLUNOMIDE
    Leflunomide
    Issue/Submission Date
    2018-09-07
    2022-10-27
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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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    • FDA
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    Mometasone Furoate

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    USDMF

    Found USDMF

    35009
    Active
    MOMETASONE FUROATE
    2020-07-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-268 - Rev 00
    Valid
    Mometasone furoate
    2021-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35009
    R0-CEP 2019-268 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE
    Mometasone furoate
    Issue/Submission Date
    2020-07-27
    2021-11-08
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    Norgestimate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21518
    Active
    NORGESTIMATE USP
    2008-04-09
    CEP/COS

    Found CEP/COS

    CEP 2017-189 - Rev 01
    Valid
    Norgestimate
    2023-09-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21518
    CEP 2017-189 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NORGESTIMATE USP
    Norgestimate
    Issue/Submission Date
    2008-04-09
    2023-09-28
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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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    Phentolamine Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16428
    Active
    PHENTOLAMINE MESILATE USP
    2003-02-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-442 - Rev 02
    Valid
    Phentolamine mesilate
    2010-12-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16428
    R1-CEP 2001-442 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PHENTOLAMINE MESILATE USP
    Phentolamine mesilate
    Issue/Submission Date
    2003-02-13
    2010-12-03
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      Pirfenidone

      PDF Supplier PDF
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      USDMF

      Found USDMF

      32796
      Active
      PIRFENIDONE
      2018-05-18
      CEP/COS

      Found CEP/COS

      R0-CEP 2018-127 - Rev 01
      Valid
      Pirfenidone
      2021-10-14
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      32796
      R0-CEP 2018-127 - Rev 01
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      PIRFENIDONE
      Pirfenidone
      Issue/Submission Date
      2018-05-18
      2021-10-14
      ASK
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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

      PDF Supplier PDF
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      See Less

      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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      Teriflunomide

      PDF Supplier PDF
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      USDMF

      Found USDMF

      36622
      Active
      TERIFLUNOMIDE
      2021-12-22
      CEP/COS

      Found CEP/COS

      R0-CEP 2022-005 - Rev 00
      Valid
      Teriflunomide
      2023-05-05
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      36622
      R0-CEP 2022-005 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      TERIFLUNOMIDE
      Teriflunomide
      Issue/Submission Date
      2021-12-22
      2023-05-05
      ASK
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      Tiotropium Bromide

      PDF Supplier PDF
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      See Less

      USDMF

      Found USDMF

      27120
      Active
      TIOTROPIUM BROMIDE
      2013-04-30
      CEP/COS

      Found CEP/COS

      R1-CEP 2016-326 - Rev 01
      Valid
      Tiotropium bromide monohydrate
      2022-12-08
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      27120
      R1-CEP 2016-326 - Rev 01
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      TIOTROPIUM BROMIDE
      Tiotropium bromide monohydrate
      Issue/Submission Date
      2013-04-30
      2022-12-08
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      Famotidine

      PDF Supplier PDF
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      See Less

      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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      Flecainide

      PDF Supplier PDF
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      See Less

      USDMF

      Caution USDMF

      24309
      Inactive
      FLECAINIDE ACETATE PROCESS II (CODE...
      2010-10-13
      CEP/COS

      Found CEP/COS

      CEP 2013-145 - Rev 02
      Valid
      Flecainide acetate, Code 50970
      2023-12-05
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      24309
      CEP 2013-145 - Rev 02
      Status
      Inactive
      Fees Paid
      N/A
      Valid
       
      Filing Details
      FLECAINIDE ACETATE PROCESS II (CODE...
      Flecainide acetate, Code 50970
      Issue/Submission Date
      2010-10-13
      2023-12-05
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      Itraconazole

      PDF Supplier PDF
      URL Supplier Web Content
      See all info for this product

      See Less

      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
      ASK
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        Lansoprazole

        PDF Supplier PDF
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        USDMF

        Found USDMF

        24487
        Active
        LANSOPRAZOLE USP
        2010-12-23
        CEP/COS

        Caution CEP/COS

        R1-CEP 2008-016 - Rev 00
        Withdrawn by Holder
        Lansoprazole
        2014-07-18
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        24487
        R1-CEP 2008-016 - Rev 00
        Status
        Active
        Fees Unpaid
        Reviewed
        Withdrawn by Holder
         
        Filing Details
        LANSOPRAZOLE USP
        Lansoprazole
        Issue/Submission Date
        2010-12-23
        2014-07-18
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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

        PDF Supplier PDF
        URL Supplier Web Content
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        See Less

        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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        Ciprofloxacin Hydrochloride

        PDF Supplier PDF
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        See Less

        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
        ASK
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        Ketorolac Trometamol

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        11980
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        KETOROLAC TROMETHAMINE
        1996-05-24
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        Application Number
        11980
        Status
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        Fees Paid
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        Filing Details
        KETOROLAC TROMETHAMINE
        Issue/Submission Date
        1996-05-24
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        Loratadine

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