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    01 Beta-Cyclodextrin (1)

    02 Beta-Cyclodextrin API (1)

    03 Carboxymethyl Cellulose Sodium (1)

    04 Carboxymethyl Ether (2)

    05 Corn Starch (1)

    06 Croscarmellose Sodium (1)

    07 Dextrose Monohydrate (1)

    08 Dibasic Calcium Phosphate (1)

    09 Hydroxypropyl Betacyclodextrin (1)

    10 Hydroxypropyl Starch Ether (1)

    11 Magnesium Stearate (1)

    12 Maltodextrin (1)

    13 Mannitol (3)

    14 Microcrystalline Cellulose (3)

    15 Pea Starch (1)

    16 Sodium Carboxymethylcellulose (1)

    17 Sodium Starch Glycolate (1)

    18 Sorbitol (2)

    19 Sorbitol API (3)

    20 Blank (1)

    filter

    01 Active (19)

    02 Inactive (5)

    03 Blank (4)

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    01 Valid (6)

    02 Blank (22)

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    01 222MF10150 (1)

    02 222MF10152 (1)

    03 Blank (26)

    filter

    01 Blank (28)

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    Dextrose Monohydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-030 - Rev 04
    Valid
    Glucose monohydrate, for use in the...
    2015-12-21
    Japanese DMF

    Found JDMF

    222MF10150
    LYCADEX PF at La Haute Loge LESTREM...
    2010-05-17
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-030 - Rev 04
    222MF10150
    Status
    Valid
     
    Filing Details
    Glucose monohydrate, for use in the...
    LYCADEX PF at La Haute Loge LESTREM...
    Issue/Submission Date
    2015-12-21
    2010-05-17
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    Mannitol

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    USDMF

    Found USDMF

    14891
    Active
    MANNITOL, SPRAY DRIED
    2000-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-039 - Rev 01
    Valid
    Mannitol
    2019-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14891
    R1-CEP 2000-039 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MANNITOL, SPRAY DRIED
    Mannitol
    Issue/Submission Date
    2000-05-16
    2019-09-12
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    Mannitol

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    USDMF

    Found USDMF

    18143
    Active
    MANNITOL USP POWDER PEARLITOL ®
    2005-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-040 - Rev 02
    Valid
    Mannitol, Spray dried
    2019-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18143
    R1-CEP 2000-040 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MANNITOL USP POWDER PEARLITOL ®
    Mannitol, Spray dried
    Issue/Submission Date
    2005-03-08
    2019-09-12
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    Sorbitol

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    USDMF

    Found USDMF

    6244
    Active
    POLYSORB 85/70/00 (SORBITOL SORBITA...
    1986-04-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-114 - Rev 04
    Valid
    Sorbitol, liquid (crystallising)
    2021-04-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6244
    R1-CEP 2001-114 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POLYSORB 85/70/00 (SORBITOL SORBITA...
    Sorbitol, liquid (crystallising)
    Issue/Submission Date
    1986-04-03
    2021-04-09
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    Carboxymethyl Ether

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    USDMF

    Found USDMF

    16854
    Active
    GLYCOLYS® SODIUM STARCH GLYCOLATE ...
    2003-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16854
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOLYS® SODIUM STARCH GLYCOLATE ...
    Issue/Submission Date
    2003-09-23
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    Hydroxypropyl Starch Ether

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    USDMF

    Found USDMF

    23919
    Active
    PEA STARCH HYDROXYPROPYL (LYCOAT r ...
    2010-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23919
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PEA STARCH HYDROXYPROPYL (LYCOAT r ...
    Issue/Submission Date
    2010-06-25
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    Mannitol

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    USDMF

    Found USDMF

    23720
    Active
    PEARLITOL FLASH
    2010-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23720
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PEARLITOL FLASH
    Issue/Submission Date
    2010-04-16
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    12299
    Active
    TABULOSE SC, MICROCRYSTALLINE CELLU...
    1996-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12299
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TABULOSE SC, MICROCRYSTALLINE CELLU...
    Issue/Submission Date
    1996-12-20
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    30748
    Active
    MICROCRYSTALLINE CELLULOSE (CELLUCR...
    2016-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30748
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICROCRYSTALLINE CELLULOSE (CELLUCR...
    Issue/Submission Date
    2016-07-13
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    Pea Starch

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    USDMF

    Found USDMF

    23917
    Active
    PREGELATINIZED HYDROXYPROPYL PEA ST...
    2010-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23917
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREGELATINIZED HYDROXYPROPYL PEA ST...
    Issue/Submission Date
    2010-06-25
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