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

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    01 2-Naphthalenepropanoic Acid (1)

    02 Benfluorexum (1)

    03 Carperitide (1)

    04 Cefmetazole (1)

    05 Cefmetazole Sodium (1)

    06 Cefpodoxime Proxetil (2)

    07 Cetraxate (2)

    08 Codeine (1)

    09 Codeine Phosphate (1)

    10 Cs 023 (1)

    11 Deruxtecan (2)

    12 Edoxaban Tosylate (1)

    13 Enkephalin, Methionine (2)

    14 Etilevodopa (1)

    15 Faropenem Medoxomil (2)

    16 Human Ghrelin (1)

    17 Hydrochlorothiazide (1)

    18 Hydromorphone Hydrochloride (1)

    19 L-VALINE (1)

    20 Levofloxacin (1)

    21 Levofloxacin Hydrochloride (1)

    22 Loxoprofen Sodium (2)

    23 MALOTILATE (1)

    24 Managlinat Dialanetil (2)

    25 Mepirizole (1)

    26 Nimustine (2)

    27 Ofloxacin (3)

    28 Olmesartan Medoxomil (7)

    29 Oxycodone Hydrochloride (1)

    30 Pantethine (1)

    31 Phenylalanine (1)

    32 Pravastatin (2)

    33 Temocapril Hydrochloride (2)

    34 Tranexamic Acid (1)

    35 Troglitazone (1)

    36 Tryptophan (1)

    37 Blank (39)

    filter

    01 Active (7)

    02 Inactive (80)

    03 Blank (6)

    filter

    01 Valid (3)

    02 Withdrawn by Holder (1)

    03 Blank (89)

    filter

    01 218MF10777 (1)

    02 218MF11021 (1)

    03 219MF10035 (1)

    04 221MF10083 (1)

    05 227MF10164 (1)

    06 227MF10256 (1)

    07 Blank (87)

    filter

    01 Blank (93)

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    • FDA
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    Ofloxacin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    4665
    Inactive
    DL-8280, BULK FORM
    1982-09-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-210 - Rev 03
    Valid
    Ofloxacin
    2015-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4665
    R1-CEP 2003-210 - Rev 03
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    DL-8280, BULK FORM
    Ofloxacin
    Issue/Submission Date
    1982-09-28
    2015-08-04
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    Olmesartan Medoxomil

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    USDMF

    Caution USDMF

    11432
    Inactive
    CS-866 DRUG PRODUCT
    1995-04-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-398 - Rev 02
    Valid
    Olmesartan medoxomil
    2022-05-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11432
    R1-CEP 2012-398 - Rev 02
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CS-866 DRUG PRODUCT
    Olmesartan medoxomil
    Issue/Submission Date
    1995-04-07
    2022-05-16
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    Pravastatin

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    USDMF

    Caution USDMF

    5968
    Inactive
    CS-514BULK SUBSTANCE PROCESSED TANA...
    1985-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-122 - Rev 05
    Valid
    Pravastatin sodium
    2016-06-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5968
    R1-CEP 2003-122 - Rev 05
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CS-514BULK SUBSTANCE PROCESSED TANA...
    Pravastatin sodium
    Issue/Submission Date
    1985-08-29
    2016-06-14
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    Codeine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10035
    Day stations codeine acid hydrate (...
    2007-02-13
    Written Confirmation

    Close WC

    Application Number
    219MF10035
    Status
     
    Filing Details
    Day stations codeine acid hydrate (...
    Issue/Submission Date
    2007-02-13
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    Codeine Phosphate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF11021
    Day stations dihydrocodeine phospha...
    2006-12-28
    Written Confirmation

    Close WC

    Application Number
    218MF11021
    Status
     
    Filing Details
    Day stations dihydrocodeine phospha...
    Issue/Submission Date
    2006-12-28
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    Deruxtecan

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    USDMF

    Found USDMF

    30003
    Active
    MAAA-1162A
    2015-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30003
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MAAA-1162A
    Issue/Submission Date
    2015-12-09
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    Deruxtecan

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    USDMF

    Found USDMF

    34021
    Active
    MAAA-1162A (COMMERCIAL)
    2019-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34021
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MAAA-1162A (COMMERCIAL)
    Issue/Submission Date
    2019-07-31
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    Etilevodopa

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    5044
    Inactive
    LEVODOPA AS PRODUCED IN THE HIRATSU...
    1983-08-09
    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-091 - Rev 03
    Withdrawn by Holder
    Levodopa
    2008-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5044
    R1-CEP 1999-091 - Rev 03
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    LEVODOPA AS PRODUCED IN THE HIRATSU...
    Levodopa
    Issue/Submission Date
    1983-08-09
    2008-05-14
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    Human Ghrelin

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    USDMF

    Found USDMF

    18461
    Active
    SUN11031 (HUMAN GHRELIN) DRUG SUBST...
    2005-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18461
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SUN11031 (HUMAN GHRELIN) DRUG SUBST...
    Issue/Submission Date
    2005-06-30
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    Hydromorphone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10256
    Hydromorphone hydrochloride at 3-5-...
    2015-10-21
    Written Confirmation

    Close WC

    Application Number
    227MF10256
    Status
     
    Filing Details
    Hydromorphone hydrochloride at 3-5-...
    Issue/Submission Date
    2015-10-21
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