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    JRS Pharma
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    Holzmühle 1 D-73494 Rosenberg
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    +49 79 67 152 312
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    • FDA
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    Sodium Alginate Excipient

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    USDMF

    Found USDMF

    34780
    Active
    SODIUM ALGINATE
    2020-07-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-169 - Rev 00
    Valid
    Sodium alginate
    2021-06-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34780
    R1-CEP 2014-169 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    SODIUM ALGINATE
    Sodium alginate
    Issue/Submission Date
    2020-07-09
    2021-06-03
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    Microcrystalline Cellulose

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    USDMF

    Caution USDMF

    6410
    Inactive
    MICROCRYSTALLINE CELLULOSE USP
    1986-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-321 - Rev 01
    Valid
    Cellulose, microcrystalline
    2014-08-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6410
    R1-CEP 2007-321 - Rev 01
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    MICROCRYSTALLINE CELLULOSE USP
    Cellulose, microcrystalline
    Issue/Submission Date
    1986-06-10
    2014-08-07
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    Carboxymethyl Ether

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    USDMF

    Found USDMF

    3479
    Active
    EXPLOTAB, SODIUM STARCH GLYCOLATE
    1979-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    3479
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    EXPLOTAB, SODIUM STARCH GLYCOLATE
    Issue/Submission Date
    1979-03-09
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    Carboxymethyl Ether

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    USDMF

    Found USDMF

    24809
    Active
    SODIUM STARCH GLYCOLATE, PH. EUR, N...
    2011-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    24809
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SODIUM STARCH GLYCOLATE, PH. EUR, N...
    Issue/Submission Date
    2011-03-31
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    Croscarmellose Sodium

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    USDMF

    Found USDMF

    24951
    Active
    CROSCARMELLOSE SODIUM, PH.EUR., NF,...
    2011-05-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24951
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    CROSCARMELLOSE SODIUM, PH.EUR., NF,...
    Issue/Submission Date
    2011-05-16
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    • FDA
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    Dextrose Monohydrate

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    USDMF

    Found USDMF

    11051
    Active
    DEXTRATES, N.F. (HYDRATED), EMDEX®
    1994-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11051
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DEXTRATES, N.F. (HYDRATED), EMDEX®
    Issue/Submission Date
    1994-08-01
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    Hypromellose

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    USDMF

    Found USDMF

    24926
    Active
    HYPROMELLOSE USP
    2011-05-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24926
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    HYPROMELLOSE USP
    Issue/Submission Date
    2011-05-04
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    • FDA
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    Maltodextrin Excipient

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF20002
    EMDEX at Holzmuehle 1 73494 Rosenbe...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    218MF20002
    Status
     
    Filing Details
    EMDEX at Holzmuehle 1 73494 Rosenbe...
    Issue/Submission Date
    2006-11-10
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    • FDA
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    6600
    Active
    EMCOCEL MICROCRYSTALLINE CELLULOSE ...
    1986-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6600
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    EMCOCEL MICROCRYSTALLINE CELLULOSE ...
    Issue/Submission Date
    1986-09-23
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    11198
    Active
    UNITAB/HEWETEN MICROCRYSTALLINE CEL...
    1994-11-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11198
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    UNITAB/HEWETEN MICROCRYSTALLINE CEL...
    Issue/Submission Date
    1994-11-11
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    11963
    Active
    MICROCRYSTALLINE CELLULOSE USP NF V...
    1996-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11963
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MICROCRYSTALLINE CELLULOSE USP NF V...
    Issue/Submission Date
    1996-05-09
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    12150
    Active
    PROSOLVE SMCC (MICROCRYSTALLINE CEL...
    1996-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12150
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROSOLVE SMCC (MICROCRYSTALLINE CEL...
    Issue/Submission Date
    1996-10-04
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    17835
    Active
    MICROCRYSTALLINE CELLULOSE
    2004-11-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17835
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MICROCRYSTALLINE CELLULOSE
    Issue/Submission Date
    2004-11-17
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    29530
    Active
    PROSOLV ODT G2
    2015-07-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29530
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROSOLV ODT G2
    Issue/Submission Date
    2015-07-02
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    Microcrystalline Cellulose

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    USDMF

    Found USDMF

    36095
    Active
    PROSOLV® 730
    2021-08-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36095
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROSOLV® 730
    Issue/Submission Date
    2021-08-14
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    • FDA
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    Sodium Stearyl Fumarate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-313 - Rev 01
    Valid
    Sodium stearyl fumarate
    2018-03-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-313 - Rev 01
    Status
    Valid
     
    Filing Details
    Sodium stearyl fumarate
    Issue/Submission Date
    2018-03-26
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    Hydrogenated cottonseed oil

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    USDMF

    Found USDMF

    12549
    Active
    LUBRITAB®
    1997-06-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12549
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LUBRITAB®
    Issue/Submission Date
    1997-06-07
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    • FDA
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    PROSOLV ODT (CO-PROCESSED EXCIPIENT FOR ORAL DISSOLVING...

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    USDMF

    Found USDMF

    26729
    Active
    PROSOLV ODT (CO-PROCESSED EXCIPIENT...
    2012-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26729
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROSOLV ODT (CO-PROCESSED EXCIPIENT...
    Issue/Submission Date
    2012-12-12
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    PROSOLV® EASYTAB

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    USDMF

    Found USDMF

    28461
    Active
    PROSOLV® EASYTAB
    2014-07-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28461
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROSOLV® EASYTAB
    Issue/Submission Date
    2014-07-01
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    VIVACOAT® READY-TO-USE FILMCOATING SYSTEM

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    USDMF

    Found USDMF

    29203
    Active
    VIVACOAT® READY-TO-USE FILMCOATING...
    2015-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29203
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    VIVACOAT® READY-TO-USE FILMCOATING...
    Issue/Submission Date
    2015-03-25
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    • FDA
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    Dibasic Calcium Phosphate

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    USDMF

    Caution USDMF

    5209
    Inactive
    EMCOMPRESS (DIBASIC CALCIUM PHOSPHA...
    1983-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5209
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    EMCOMPRESS (DIBASIC CALCIUM PHOSPHA...
    Issue/Submission Date
    1983-12-30
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    Hypromellose, Unspecified

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    USDMF

    Caution USDMF

    11797
    Inactive
    NONPAREILS (SUGAR SPHERES NF)
    1995-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11797
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    NONPAREILS (SUGAR SPHERES NF)
    Issue/Submission Date
    1995-10-27
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    SUGAR PRODUCT TO BE USED AS A NON-ACTIVE INGREDIENT BY ...

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    USDMF

    Caution USDMF

    1195
    Inactive
    SUGAR PRODUCT TO BE USED AS A NON-A...
    1968-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1195
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    SUGAR PRODUCT TO BE USED AS A NON-A...
    Issue/Submission Date
    1968-06-17
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