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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Xellia Pharmaceuticals Aps

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    01 Amphotericin B (2)

    02 Bacitracin Zinc (6)

    03 Caspofungin (1)

    04 Colistimethate Sodium (2)

    05 Colistin Sulfate (1)

    06 Daptomycin (1)

    07 Fluticasone Propionate (1)

    08 Gramicidin (2)

    09 Mometasone Furoate (1)

    10 Mupirocin (1)

    11 Polymyxin B Sulfate (2)

    12 Tobramycin (2)

    13 Tobramycin Sulfate (1)

    14 Tyrothricin (1)

    15 Vancomycin Hydrochloride (4)

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    01 Active (17)

    02 Inactive (5)

    03 Blank (6)

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    01 Valid (15)

    02 Blank (13)

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    01 218MF10934 (1)

    02 218MF10935 (1)

    03 218MF10936 (1)

    04 219MF10071 (1)

    05 219MF10091 (1)

    06 219MF10216 (1)

    07 219MF10325 (1)

    08 221MF10171 (1)

    09 221MF10198 (1)

    10 223MF10046 (1)

    11 225MF10193 (1)

    12 228MF10078 (1)

    13 228MF10200 (1)

    14 303MF10154 (1)

    15 Blank (14)

    filter

    01 Blank (28)

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    Amphotericin B

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13682
    Active
    AMPHOTERICIN B
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-079 - Rev 09
    Valid
    Amphotericin B
    2023-05-12
    Japanese DMF

    Found JDMF

    303MF10154
    Amphotericin B at Dalslandsgade 11,...
    2021-09-28
    Written Confirmation

    Close WC

    Application Number
    13682
    R1-CEP 2002-079 - Rev 09
    303MF10154
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMPHOTERICIN B
    Amphotericin B
    Amphotericin B at Dalslandsgade 11,...
    Issue/Submission Date
    1998-09-01
    2023-05-12
    2021-09-28
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    Bacitracin Zinc

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13341
    Active
    BACITRACIN STERILE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-224 - Rev 08
    Valid
    Bacitracin, Sterile
    2018-02-07
    Japanese DMF

    Found JDMF

    225MF10193
    Japanese Pharmacopoeia bacitracin a...
    2013-10-09
    Written Confirmation

    Close WC

    Application Number
    13341
    R1-CEP 2002-224 - Rev 08
    225MF10193
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BACITRACIN STERILE USP
    Bacitracin, Sterile
    Japanese Pharmacopoeia bacitracin a...
    Issue/Submission Date
    1998-09-01
    2018-02-07
    2013-10-09
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    Colistimethate Sodium

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    USDMF

    Found USDMF

    13363
    Active
    COLISTIMETHATE SODIUM USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-209 - Rev 05
    Valid
    Colistimethate sodium
    2017-07-19
    Japanese DMF

    Found JDMF

    221MF10198
    Colistin sodium methanesulfonate at...
    2009-09-14
    Written Confirmation

    Close WC

    Application Number
    13363
    R1-CEP 2000-209 - Rev 05
    221MF10198
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    COLISTIMETHATE SODIUM USP
    Colistimethate sodium
    Colistin sodium methanesulfonate at...
    Issue/Submission Date
    1998-09-01
    2017-07-19
    2009-09-14
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    Polymyxin B Sulfate

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    USDMF

    Found USDMF

    13536
    Active
    POLYMYXIN B SULFATE, STERILE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-061 - Rev 05
    Valid
    Polymyxin B sulfate
    2018-11-21
    Japanese DMF

    Found JDMF

    219MF10071
    Polymyxin B sulfate sterile at Dals...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    13536
    R1-CEP 1998-061 - Rev 05
    219MF10071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    POLYMYXIN B SULFATE, STERILE
    Polymyxin B sulfate
    Polymyxin B sulfate sterile at Dals...
    Issue/Submission Date
    1998-09-01
    2018-11-21
    2007-03-14
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    Polymyxin B Sulfate

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    USDMF

    Found USDMF

    14187
    Active
    POLYMYXIN B SULFATE
    1999-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-062 - Rev 06
    Valid
    Polymyxin B sulfate, Sterile
    2019-04-05
    Japanese DMF

    Found JDMF

    218MF10934
    Polymyxin B sulfate salt at Dalslan...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    14187
    R1-CEP 1998-062 - Rev 06
    218MF10934
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    POLYMYXIN B SULFATE
    Polymyxin B sulfate, Sterile
    Polymyxin B sulfate salt at Dalslan...
    Issue/Submission Date
    1999-06-10
    2019-04-05
    2006-11-21
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    13691
    Active
    VANCOMYCIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-110 - Rev 10
    Valid
    Vancomycin hydrochloride
    2023-02-21
    Japanese DMF

    Found JDMF

    219MF10091
    Vancomycin-based, dry at Dalslandsg...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    13691
    R1-CEP 1999-110 - Rev 10
    219MF10091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin-based, dry at Dalslandsg...
    Issue/Submission Date
    1998-09-01
    2023-02-21
    2007-03-14
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    13794
    Active
    VANCOMYCIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-195 - Rev 02
    Valid
    Vancomycin hydrochloride
    2019-08-30
    Japanese DMF

    Found JDMF

    221MF10171
    Vancomycin hydrochloride at H-1107 ...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    13794
    R1-CEP 2007-195 - Rev 02
    221MF10171
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin hydrochloride at H-1107 ...
    Issue/Submission Date
    1998-09-01
    2019-08-30
    2009-07-30
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    20614
    Active
    VANCOMYCIN HYDROCHLORIDE
    2007-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-006 - Rev 10
    Valid
    Vancomycin hydrochloride
    2019-12-03
    Japanese DMF

    Found JDMF

    219MF10216
    Vancomycin hydrochloride sterile go...
    2007-06-25
    Written Confirmation

    Close WC

    Application Number
    20614
    R1-CEP 1996-006 - Rev 10
    219MF10216
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin hydrochloride sterile go...
    Issue/Submission Date
    2007-06-11
    2019-12-03
    2007-06-25
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    Bacitracin Zinc

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    USDMF

    Caution USDMF

    13388
    Inactive
    BACITRACIN ZINC STERILE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-226 - Rev 07
    Valid
    Bacitracin
    2022-04-06
    Japanese DMF

    Found JDMF

    218MF10935
    Japanese Pharmacopoeia bacitracin a...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13388
    R1-CEP 2002-226 - Rev 07
    218MF10935
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BACITRACIN ZINC STERILE USP
    Bacitracin
    Japanese Pharmacopoeia bacitracin a...
    Issue/Submission Date
    1998-09-01
    2022-04-06
    2006-11-21
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    Gramicidin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13494
    Inactive
    GRAMICIDIN
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-132 - Rev 06
    Valid
    Gramicidin
    2018-12-18
    Japanese DMF

    Found JDMF

    218MF10936
    Gramicidin at H-1107 Budapest, Sza(...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13494
    R1-CEP 2006-132 - Rev 06
    218MF10936
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GRAMICIDIN
    Gramicidin
    Gramicidin at H-1107 Budapest, Sza(...
    Issue/Submission Date
    1998-09-01
    2018-12-18
    2006-11-21
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