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

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    Benzalkonium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-298 - Rev 02
    Valid
    Benzalkonium chloride
    2015-10-16
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2001-298 - Rev 02
    Status
    Valid
     
    Filing Details
    Benzalkonium chloride
    Issue/Submission Date
    2015-10-16
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    Benzyldimethyltridecylazanium Chloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2000-123 - Rev 03
    Valid
    Benzalkonium chloride solution
    2015-10-16
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2000-123 - Rev 03
    Status
    Valid
     
    Filing Details
    Benzalkonium chloride solution
    Issue/Submission Date
    2015-10-16
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    Bovine Insulin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-230 - Rev 00
    Valid
    Insulin, bovine
    2006-05-17
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2000-230 - Rev 00
    Status
    Valid
     
    Filing Details
    Insulin, bovine
    Issue/Submission Date
    2006-05-17
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    Cetrimide

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2003-186 - Rev 02
    Valid
    Cetrimide
    2022-01-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2003-186 - Rev 02
    Status
    Valid
     
    Filing Details
    Cetrimide
    Issue/Submission Date
    2022-01-03
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    Bovine Insulin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2000-135 - Rev 02
    Withdrawn by Holder
    Insulin, bovine, \"monocomponent\"
    2005-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2000-135 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Insulin, bovine, \"monocomponent\"
    Issue/Submission Date
    2005-03-08
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    Bovine Insulin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2000-340 - Rev 02
    Withdrawn by Holder
    Insulin, bovine, \"chromatographed\...
    2005-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2000-340 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Insulin, bovine, \"chromatographed\...
    Issue/Submission Date
    2005-03-08
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    Caninsulin

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    USDMF

    Caution USDMF

    3402
    Inactive
    INSULIN USP(MONOCOMPONENT-MC)
    1979-01-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3402
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    INSULIN USP(MONOCOMPONENT-MC)
    Issue/Submission Date
    1979-01-12
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    Glucagon

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    USDMF

    Caution USDMF

    2961
    Inactive
    GLUCAGON (BULK)
    1977-06-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2961
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    GLUCAGON (BULK)
    Issue/Submission Date
    1977-06-07
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    Glucagon

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    USDMF

    Caution USDMF

    3738
    Inactive
    ZINC PROTAMINE GLUCAGON NOVO, PREPA...
    1980-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3738
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ZINC PROTAMINE GLUCAGON NOVO, PREPA...
    Issue/Submission Date
    1980-03-14
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    • FDA
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    Insulin

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    USDMF

    Caution USDMF

    3536
    Inactive
    INSULINS, USP--PREPARATION AND PACK...
    1979-06-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3536
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    INSULINS, USP--PREPARATION AND PACK...
    Issue/Submission Date
    1979-06-14
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    Insulin

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    USDMF

    Caution USDMF

    3830
    Inactive
    PURIFIED INSULIN
    1980-05-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3830
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PURIFIED INSULIN
    Issue/Submission Date
    1980-05-30
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    Insulin

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    USDMF

    Caution USDMF

    5758
    Inactive
    PRODUCTION OF INSULIN
    1985-02-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5758
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PRODUCTION OF INSULIN
    Issue/Submission Date
    1985-02-18
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    Insulin Lispro

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    USDMF

    Caution USDMF

    5527
    Inactive
    HUMAN INSULIN (SEMI-SYNTHETIC) AS P...
    1984-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5527
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    HUMAN INSULIN (SEMI-SYNTHETIC) AS P...
    Issue/Submission Date
    1984-09-14
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    Insulin Lispro

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    USDMF

    Caution USDMF

    5533
    Inactive
    HUMAN INSULIN INJ NEUTRAL 500 UNITS...
    1984-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5533
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    HUMAN INSULIN INJ NEUTRAL 500 UNITS...
    Issue/Submission Date
    1984-09-14
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    Insulin, Regular, Pork

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    USDMF

    Caution USDMF

    2732
    Inactive
    INSULIN (SALT CAKE AND CRYSTALS)
    1976-08-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2732
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    INSULIN (SALT CAKE AND CRYSTALS)
    Issue/Submission Date
    1976-08-30
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    Norethisterone Acetate

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    USDMF

    Caution USDMF

    6353
    Inactive
    NORETHINDRONE ACETATE
    1986-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6353
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NORETHINDRONE ACETATE
    Issue/Submission Date
    1986-05-15
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    Nortropin

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    USDMF

    Caution USDMF

    6970
    Inactive
    NORDITROPIN (BIOSYNTHETIC HUMAN GRO...
    1987-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6970
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NORDITROPIN (BIOSYNTHETIC HUMAN GRO...
    Issue/Submission Date
    1987-04-14
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    SUBTILISIN A SUBSTRATE I

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    USDMF

    Caution USDMF

    8133
    Inactive
    SUBTILISIN A
    1989-07-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8133
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SUBTILISIN A
    Issue/Submission Date
    1989-07-14
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    Trypsin

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    USDMF

    Caution USDMF

    1537
    Inactive
    CRYSTALLINE TRYPSIN NOVO
    1970-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1537
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CRYSTALLINE TRYPSIN NOVO
    Issue/Submission Date
    1970-06-09
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    • FDA
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    AMYLASE CONCENTRATE, CRUDE BACTERIAL

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    USDMF

    Caution USDMF

    335
    Inactive
    AMYLASE CONCENTRATE, CRUDE BACTERIA...
    1940-01-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    335
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AMYLASE CONCENTRATE, CRUDE BACTERIA...
    Issue/Submission Date
    1940-01-01
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    CRYSTALLINE PORCINE TYPSIN, NOVO (FOR G,CONTROL SEE D-5...

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    USDMF

    Caution USDMF

    723
    Inactive
    CRYSTALLINE PORCINE TYPSIN, NOVO (F...
    1963-07-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    723
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CRYSTALLINE PORCINE TYPSIN, NOVO (F...
    Issue/Submission Date
    1963-07-11
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    • FDA
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    BOVINE PROTEOLYTIC ENZYME MIXTURE (BOVINE PEM) BVF 800...

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    USDMF

    Caution USDMF

    1536
    Inactive
    BOVINE PROTEOLYTIC ENZYME MIXTURE ...
    1970-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1536
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BOVINE PROTEOLYTIC ENZYME MIXTURE ...
    Issue/Submission Date
    1970-06-09
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    • FDA
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    FACILITIES IN BAGSVAERD, KALUNDBORG, COPENHAGEN, SOEBER...

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    USDMF

    Caution USDMF

    10480
    Inactive
    FACILITIES IN BAGSVAERD, KALUNDBORG...
    1993-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10480
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FACILITIES IN BAGSVAERD, KALUNDBORG...
    Issue/Submission Date
    1993-09-02
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    FACILITIES AND PROCEDURES IN DENMARK

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    USDMF

    Caution USDMF

    10603
    Inactive
    FACILITIES AND PROCEDURES IN DENMAR...
    1993-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10603
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FACILITIES AND PROCEDURES IN DENMAR...
    Issue/Submission Date
    1993-11-29
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    5-CNAC

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    USDMF

    Caution USDMF

    14697
    Inactive
    5-CNAC
    2000-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14697
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    5-CNAC
    Issue/Submission Date
    2000-02-03
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