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    Corbion
    Netherlands1 Flag
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    Netherlands
    Address
    Address
    Piet Heinkade 127 1019 GM AMSTERDAM
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    Telephone
    +31 20 590 6911
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    enquiries@pharmacompass.com
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    Website
    https://www.corbion.com/
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    Sodium Lactate

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    USDMF

    Found USDMF

    20598
    Active
    SODIUM (S)-LACTATE SOLUTION 50%, 60...
    2007-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-038 - Rev 01
    Valid
    Sodium (S)-lactate solution
    2014-10-06
    Japanese DMF

    Found JDMF

    222MF10244
    PURASAL S PF 60 at P. O. BOX21, Gor...
    2010-10-21
    Written Confirmation

    Close WC

    Application Number
    20598
    R1-CEP 1999-038 - Rev 01
    222MF10244
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    SODIUM (S)-LACTATE SOLUTION 50%, 60...
    Sodium (S)-lactate solution
    PURASAL S PF 60 at P. O. BOX21, Gor...
    Issue/Submission Date
    2007-06-11
    2014-10-06
    2010-10-21
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    L-Lactic Acid

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    USDMF

    Found USDMF

    20726
    Active
    L(+)LACTIC ACID
    2007-07-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-124 - Rev 01
    Valid
    (S)-Lactic acid
    2023-04-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20726
    R1-CEP 2006-124 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    L(+)LACTIC ACID
    (S)-Lactic acid
    Issue/Submission Date
    2007-07-26
    2023-04-27
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    Calcium Gluconate

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    USDMF

    Caution USDMF

    8438
    Inactive
    CALCIUM GLUCONATE
    1990-02-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-095 - Rev 01
    Valid
    Calcium gluconate
    2018-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8438
    R1-CEP 2012-095 - Rev 01
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CALCIUM GLUCONATE
    Calcium gluconate
    Issue/Submission Date
    1990-02-05
    2018-11-23
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    Calcium Gluconate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-094 - Rev 01
    Valid
    Calcium gluconate for injection
    2018-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-094 - Rev 01
    Status
    Valid
     
    Filing Details
    Calcium gluconate for injection
    Issue/Submission Date
    2018-09-27
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    Calcium Lactate API

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-157 - Rev 00
    Valid
    Calcium lactate pentahydrate
    2018-06-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-157 - Rev 00
    Status
    Valid
     
    Filing Details
    Calcium lactate pentahydrate
    Issue/Submission Date
    2018-06-19
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    Sodium Lactate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10185
    PURASAL S / PF 60 (5.3) at P. O. BO...
    2007-06-01
    Written Confirmation

    Close WC

    Application Number
    219MF10185
    Status
     
    Filing Details
    PURASAL S / PF 60 (5.3) at P. O. BO...
    Issue/Submission Date
    2007-06-01
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    Sodium Lactate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10186
    PURASAL S / PF 60 (7.4) at P. O. BO...
    2007-06-01
    Written Confirmation

    Close WC

    Application Number
    219MF10186
    Status
     
    Filing Details
    PURASAL S / PF 60 (7.4) at P. O. BO...
    Issue/Submission Date
    2007-06-01
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    Sodium Lactate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10464
    PURASAL S PF 50 at P. O. BOX21, Gor...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    218MF10464
    Status
     
    Filing Details
    PURASAL S PF 50 at P. O. BOX21, Gor...
    Issue/Submission Date
    2006-04-27
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    Ammonium Lactate

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    USDMF

    Caution USDMF

    11075
    Inactive
    AMMONIUM LACTATE, PURASAL NH 70
    1994-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11075
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AMMONIUM LACTATE, PURASAL NH 70
    Issue/Submission Date
    1994-09-13
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    Calcium Gluconate

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1995-020 - Rev 07
    Withdrawn by Holder
    Calcium gluconate
    2009-05-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1995-020 - Rev 07
    Status
    Withdrawn by Holder
     
    Filing Details
    Calcium gluconate
    Issue/Submission Date
    2009-05-28
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    Calcium Gluconate

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-246 - Rev 01
    Withdrawn by Holder
    Calcium gluconate for injection
    2009-05-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-246 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Calcium gluconate for injection
    Issue/Submission Date
    2009-05-28
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    Zinc Gluconate API

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    USDMF

    Caution USDMF

    6002
    Inactive
    ZINC GLUCONATE
    1985-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6002
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ZINC GLUCONATE
    Issue/Submission Date
    1985-07-30
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