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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Industriale Chimica s.r.l.

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    INDUSTRIALE CHIMICA S.R.L.

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    Industriale Chimica s.r.l.
    Italy Flag
    Country
    Country
    Italy
    Address
    Address
    Via E. H. Grieg, 13 21047 Saronno (VA)
    Telephone
    Telephone
    +39 02 964 26 401
    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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    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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    • 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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    • FDA
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    Formoterol Fumarate

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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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    • FDA
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    Bumetanide

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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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    Desogestrel

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    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

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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

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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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    • 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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    • FDA
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    Indapamide

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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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    • FDA
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    Latanoprost

    PDF Supplier PDF
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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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    • 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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    • FDA
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    Phentolamine Mesylate

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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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    • FDA
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    Tiotropium Bromide

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    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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    Abiraterone Acetate

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    USDMF

    Found USDMF

    28701
    Active
    ABIRATERONE ACETATE USP
    2014-10-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28701
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABIRATERONE ACETATE USP
    Issue/Submission Date
    2014-10-08
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    Abiraterone Acetate

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    USDMF

    Found USDMF

    34320
    Active
    ABIRATERONE ACETATE USP (NP)
    2019-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34320
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABIRATERONE ACETATE USP (NP)
    Issue/Submission Date
    2019-12-12
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    Beclomethasone Dipropionate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-108 - Rev 00
    Valid
    Beclometasone dipropionate
    2021-04-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-108 - Rev 00
    Status
    Valid
     
    Filing Details
    Beclometasone dipropionate
    Issue/Submission Date
    2021-04-30
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    Beclomethasone Dipropionate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-468 - Rev 00
    Valid
    Beclometasone dipropionate monohydr...
    2022-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-468 - Rev 00
    Status
    Valid
     
    Filing Details
    Beclometasone dipropionate monohydr...
    Issue/Submission Date
    2022-03-17
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    Bimatoprost

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23480
    Active
    BIMATOPROST
    2010-01-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23480
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BIMATOPROST
    Issue/Submission Date
    2010-01-26
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    Brinzolamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25918
    Active
    BRINZOLAMIDE, USP
    2012-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25918
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BRINZOLAMIDE, USP
    Issue/Submission Date
    2012-03-28
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    Budesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20010
    Active
    BUDESONIDE USP
    2006-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20010
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUDESONIDE USP
    Issue/Submission Date
    2006-11-30
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    Desogestrel

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10126
    Desogestrel at Via E. H. Greig, 13,...
    2009-06-23
    Written Confirmation

    Close WC

    Application Number
    221MF10126
    Status
     
    Filing Details
    Desogestrel at Via E. H. Greig, 13,...
    Issue/Submission Date
    2009-06-23
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    Dofetilide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30042
    Active
    DOFETILIDE USP
    2015-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30042
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOFETILIDE USP
    Issue/Submission Date
    2015-12-17
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    Drospirenone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-081 - Rev 00
    Valid
    Drospirenone
    2016-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-081 - Rev 00
    Status
    Valid
     
    Filing Details
    Drospirenone
    Issue/Submission Date
    2016-03-24
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    Eplerenone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32998
    Active
    EPLERENONE PH. EUR.
    2018-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32998
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPLERENONE PH. EUR.
    Issue/Submission Date
    2018-11-30
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    Etonogestrel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29165
    Active
    ETONOGESTREL
    2015-04-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29165
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ETONOGESTREL
    Issue/Submission Date
    2015-04-20
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    Fampridine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27623
    Active
    DALFAMPRIDINE
    2013-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27623
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALFAMPRIDINE
    Issue/Submission Date
    2013-10-18
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    Fluticasone Furoate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10120
    Fluticasone Furoate at Via E. H. Gr...
    2023-11-15
    Written Confirmation

    Close WC

    Application Number
    305MF10120
    Status
     
    Filing Details
    Fluticasone Furoate at Via E. H. Gr...
    Issue/Submission Date
    2023-11-15
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    • FDA
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    Formoterol Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20199
    Active
    FORMOTEROL FUMARATE DIHYDRATE USP
    2007-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20199
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FORMOTEROL FUMARATE DIHYDRATE USP
    Issue/Submission Date
    2007-01-18
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    Gestodene

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-181 - Rev 01
    Valid
    Gestodene
    2020-05-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-181 - Rev 01
    Status
    Valid
     
    Filing Details
    Gestodene
    Issue/Submission Date
    2020-05-15
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    Idebenone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18428
    Active
    IDEBENONE
    2005-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18428
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IDEBENONE
    Issue/Submission Date
    2005-06-08
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    Ivermectin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36494
    Active
    IVERMECTIN PH. FUR.
    2021-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36494
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IVERMECTIN PH. FUR.
    Issue/Submission Date
    2021-11-15
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    • FDA
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    Loteprednol Etabonate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23672
    Active
    LOTEPREDNOL ETABONATE
    2010-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23672
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LOTEPREDNOL ETABONATE
    Issue/Submission Date
    2010-04-01
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    Memantine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    19465
    Active
    MEMANTINE HYDROCHLORIDE USP
    2006-05-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19465
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Issue/Submission Date
    2006-05-22
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    Midodrine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    16006
    Active
    MIDODRINE HYDROCHLORIDE
    2002-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16006
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIDODRINE HYDROCHLORIDE
    Issue/Submission Date
    2002-06-13
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    Mometasone Furoate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-103 - Rev 00
    Valid
    Mometasone furoate monohydrate
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-103 - Rev 00
    Status
    Valid
     
    Filing Details
    Mometasone furoate monohydrate
    Issue/Submission Date
    2022-05-19
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    • FDA
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    Nitazoxanide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23792
    Active
    NITAZOXANIDE
    2010-05-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23792
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NITAZOXANIDE
    Issue/Submission Date
    2010-05-06
    ASK
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    Nomegestrol Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-038 - Rev 01
    Valid
    Nomegestrol acetate
    2021-04-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-038 - Rev 01
    Status
    Valid
     
    Filing Details
    Nomegestrol acetate
    Issue/Submission Date
    2021-04-01
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    Norgestimate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33444
    Active
    NORGESTIMATE USP (NP)
    2019-02-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33444
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NORGESTIMATE USP (NP)
    Issue/Submission Date
    2019-02-05
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    Obeticholic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33776
    Active
    OBETICHOLIC ACID
    2019-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33776
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OBETICHOLIC ACID
    Issue/Submission Date
    2019-06-05
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    Pentazocine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13983
    Active
    PENTAZOCINE HYDROCHLORIDE
    1999-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13983
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PENTAZOCINE HYDROCHLORIDE
    Issue/Submission Date
    1999-02-09
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    Progesterone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    35541
    Active
    PROGESTERONE USP
    2021-01-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35541
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PROGESTERONE USP
    Issue/Submission Date
    2021-01-13
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    Salmeterol Xinafoate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-107 - Rev 01
    Valid
    Salmeterol xinafoate
    2022-03-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-107 - Rev 01
    Status
    Valid
     
    Filing Details
    Salmeterol xinafoate
    Issue/Submission Date
    2022-03-18
    ASK
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    • FDA
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    Tibolone

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-336 - Rev 00
    Valid
    Tibolone
    2015-07-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-336 - Rev 00
    Status
    Valid
     
    Filing Details
    Tibolone
    Issue/Submission Date
    2015-07-10
    ASK
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    • FDA
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    Ulipristal Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32954
    Active
    ULIPRISTAL ACETATE
    2018-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32954
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ULIPRISTAL ACETATE
    Issue/Submission Date
    2018-07-27
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