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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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    • FDA
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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 2001-113 - Rev 02
    Valid
    Sorbitol
    2019-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6244
    R1-CEP 2001-113 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POLYSORB 85/70/00 (SORBITOL SORBITA...
    Sorbitol
    Issue/Submission Date
    1986-04-03
    2019-12-05
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    • FDA
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    Beta-Cyclodextrin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-307 - Rev 00
    Valid
    Betadex
    2017-02-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-307 - Rev 00
    Status
    Valid
     
    Filing Details
    Betadex
    Issue/Submission Date
    2017-02-13
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    Beta-Cyclodextrin API

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    USDMF

    Found USDMF

    9155
    Active
    BETA CYCLODEXTRIN
    1991-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9155
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BETA CYCLODEXTRIN
    Issue/Submission Date
    1991-06-10
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    • FDA
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    Carboxymethyl Cellulose Sodium

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    USDMF

    Found USDMF

    7651
    Active
    GLYCOLYS@SODIUM STARCH GLYCOLATE NF
    1988-08-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7651
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOLYS@SODIUM STARCH GLYCOLATE NF
    Issue/Submission Date
    1988-08-22
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    • FDA
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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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    • FDA
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    Corn Starch

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    USDMF

    Found USDMF

    30976
    Active
    PREGELATINIZED MAIZE STARCH (GELMAC...
    2016-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30976
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREGELATINIZED MAIZE STARCH (GELMAC...
    Issue/Submission Date
    2016-09-20
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    Croscarmellose Sodium

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    USDMF

    Found USDMF

    9362
    Active
    SOLUTAB CROSCARMELLOSE SODIUM
    1991-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9362
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SOLUTAB CROSCARMELLOSE SODIUM
    Issue/Submission Date
    1991-08-27
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    • FDA
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    Dibasic Calcium Phosphate

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    USDMF

    Found USDMF

    31776
    Active
    DIBASIC CALCIUM PHOSPHATE (CRESTADD...
    2017-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31776
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIBASIC CALCIUM PHOSPHATE (CRESTADD...
    Issue/Submission Date
    2017-05-19
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    • FDA
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    Hydroxypropyl Betacyclodextrin

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    USDMF

    Found USDMF

    9420
    Active
    HYDROXY-PROPYL BETA-CYCLODEXTRIN
    1991-11-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9420
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDROXY-PROPYL BETA-CYCLODEXTRIN
    Issue/Submission Date
    1991-11-22
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    • FDA
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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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    • FDA
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    Magnesium Stearate

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    USDMF

    Found USDMF

    32441
    Active
    MAGNESIUM STEARATE (LUBRICREST)
    2018-01-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32441
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MAGNESIUM STEARATE (LUBRICREST)
    Issue/Submission Date
    2018-01-08
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    • FDA
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    Mannitol

    PDF Supplier PDF
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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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    • FDA
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    Microcrystalline Cellulose

    PDF Supplier PDF
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    USDMF

    Found USDMF

    9201
    Active
    MICROCEL MICROCRYSTALLINE CELLULOSE
    1991-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9201
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICROCEL MICROCRYSTALLINE CELLULOSE
    Issue/Submission Date
    1991-06-17
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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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    • FDA
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    Pea Starch

    PDF Supplier PDF
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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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    • FDA
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    Sodium Carboxymethylcellulose

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    USDMF

    Found USDMF

    32790
    Active
    CROSCARMELLOSE SODIUM (CRESTCROSS)
    2018-04-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32790
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CROSCARMELLOSE SODIUM (CRESTCROSS)
    Issue/Submission Date
    2018-04-27
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    • FDA
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    Sodium Starch Glycolate

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    USDMF

    Found USDMF

    31775
    Active
    SODIUM STARCH GLYCOLATE (RAPIGEL)
    2017-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31775
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM STARCH GLYCOLATE (RAPIGEL)
    Issue/Submission Date
    2017-05-19
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    • FDA
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    Sorbitol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    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
    R1-CEP 2001-114 - Rev 04
    Status
    Valid
     
    Filing Details
    Sorbitol, liquid (crystallising)
    Issue/Submission Date
    2021-04-09
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    Sorbitol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10152
    NEOSORB PF at La Haute Loge LESTREM...
    2010-05-17
    Written Confirmation

    Close WC

    Application Number
    222MF10152
    Status
     
    Filing Details
    NEOSORB PF at La Haute Loge LESTREM...
    Issue/Submission Date
    2010-05-17
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    • FDA
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    Carboxymethyl Ether

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    3495
    Inactive
    EXPLOTAB BRAND OF SODIUM STARCH GLY...
    1979-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3495
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    EXPLOTAB BRAND OF SODIUM STARCH GLY...
    Issue/Submission Date
    1979-03-16
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    • FDA
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    Maltodextrin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11462
    Inactive
    MALTODEXTRIN FOR PERITONEAL DIALYSI...
    1995-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11462
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MALTODEXTRIN FOR PERITONEAL DIALYSI...
    Issue/Submission Date
    1995-04-21
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    • FDA
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    Sorbitol API

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    5656
    Inactive
    LYCASIN BRAND HYDROGENATED GLUCOSE ...
    1984-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5656
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LYCASIN BRAND HYDROGENATED GLUCOSE ...
    Issue/Submission Date
    1984-11-05
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    • FDA
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    Sorbitol API

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    6611
    Inactive
    LYCASIN BRAND OF HYDROGENATED GLUCO...
    1986-10-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6611
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LYCASIN BRAND OF HYDROGENATED GLUCO...
    Issue/Submission Date
    1986-10-02
    ASK
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    • FDA
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    Sorbitol API

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    10879
    Inactive
    NEOSORB 70/20 SORBITOL SOLUTION
    1994-04-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10879
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NEOSORB 70/20 SORBITOL SOLUTION
    Issue/Submission Date
    1994-04-15
    ASK
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