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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Corbion

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    01 Ammonium Lactate (1)

    02 Calcium Gluconate (4)

    03 Calcium Lactate API (1)

    04 L-Lactic Acid (1)

    05 Sodium Lactate (4)

    06 Zinc Gluconate API (1)

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    01 Active (2)

    02 Inactive (3)

    03 Blank (7)

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    01 Valid (5)

    02 Withdrawn by Holder (2)

    03 Blank (5)

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    01 218MF10464 (1)

    02 219MF10185 (1)

    03 219MF10186 (1)

    04 222MF10244 (1)

    05 Blank (8)

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    01 Blank (12)

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    • FDA
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    Sodium Lactate

    PDF Supplier PDF
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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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