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    01 Dextrose Monohydrate API (1)

    02 Glucose (1)

    03 Hydroxypropyl-Beta Cyclodextrin (1)

    04 Isosorbide (1)

    05 Mannitol API (3)

    06 Polydextrose (1)

    07 SODIUM STARCH GLYOLATE (1)

    08 Sodium Gluconate (1)

    09 Sodium Lactate (1)

    10 Sorbitol API (1)

    11 Blank (1)

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    01 Active (7)

    02 Inactive (4)

    03 Blank (2)

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    01 Valid (1)

    02 Withdrawn by Holder (1)

    03 Blank (11)

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    01 218MF10543 (1)

    02 225MF10097 (1)

    03 Blank (11)

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    01 Blank (13)

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    Hydroxypropyl-Beta Cyclodextrin

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    USDMF

    Found USDMF

    30897
    Active
    HYDROXYPROPYL BETADEX
    2016-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-264 - Rev 00
    Valid
    Hydroxypropylbetadex, MS 0.58-0.68,...
    2022-04-04
    Japanese DMF

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    Written Confirmation

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    Application Number
    30897
    R1-CEP 2015-264 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    HYDROXYPROPYL BETADEX
    Hydroxypropylbetadex, MS 0.58-0.68,...
    Issue/Submission Date
    2016-08-29
    2022-04-04
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    Polydextrose

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    USDMF

    Found USDMF

    37662
    Active
    ROQUETTE® POLYDEXTRIN (Icodextrin)
    2022-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10097
    POLYDEXTRIN at La Haute Loge LESTRE...
    2013-05-08
    Written Confirmation

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    Application Number
    37662
    225MF10097
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ROQUETTE® POLYDEXTRIN (Icodextrin)
    POLYDEXTRIN at La Haute Loge LESTRE...
    Issue/Submission Date
    2022-12-20
    2013-05-08
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    Dextrose Monohydrate API

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    USDMF

    Found USDMF

    4697
    Active
    DEXTROSE MONOHYDRATE USP GRADE (LYC...
    1982-10-27
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    4697
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROSE MONOHYDRATE USP GRADE (LYC...
    Issue/Submission Date
    1982-10-27
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    Glucose

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    USDMF

    Found USDMF

    11059
    Active
    DEXTROSE MONOHYDRATE, USP GRADE
    1994-09-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11059
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROSE MONOHYDRATE, USP GRADE
    Issue/Submission Date
    1994-09-01
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    Isosorbide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10543
    ISOSORBIDE C PHARMA at La Haute Log...
    2006-06-01
    Written Confirmation

    Close WC

    Application Number
    218MF10543
    Status
     
    Filing Details
    ISOSORBIDE C PHARMA at La Haute Log...
    Issue/Submission Date
    2006-06-01
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    Mannitol API

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    USDMF

    Found USDMF

    12879
    Active
    MANNITOL USP GRADE (PEARLITOL PF)
    1998-02-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    12879
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MANNITOL USP GRADE (PEARLITOL PF)
    Issue/Submission Date
    1998-02-26
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    Sodium Gluconate

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    USDMF

    Found USDMF

    34499
    Active
    SODIUM GLUCONATE
    2020-01-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34499
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM GLUCONATE
    Issue/Submission Date
    2020-01-15
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    Sorbitol API

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    USDMF

    Found USDMF

    34930
    Active
    SORBITOL POWDER PYROGEN FREE
    2020-06-09
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    34930
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SORBITOL POWDER PYROGEN FREE
    Issue/Submission Date
    2020-06-09
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    Mannitol API

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    USDMF

    Caution USDMF

    5443
    Inactive
    MANNITOL
    1984-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    5443
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANNITOL
    Issue/Submission Date
    1984-06-29
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    Mannitol API

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    USDMF

    Caution USDMF

    6650
    Inactive
    MANNITOL GRANULAR G.G.
    1986-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    6650
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANNITOL GRANULAR G.G.
    Issue/Submission Date
    1986-10-29
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