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    INACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS BY APPLICATIONS

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    BIO-Europe Spring
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    Jrs Pharma Lp

    Germany
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    BIO-Europe Spring
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11051

    Submission : 1994-08-01

    Status : Active

    Type : IV

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    Shandong Tianli Pharmaceutical Co Lt...

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    BIO-Europe Spring
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37618

    Submission : 2023-03-30

    Status : Active

    Type : II

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    BIO-Europe Spring
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33205

    Submission : 2018-10-11

    Status : Active

    Type : II

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    JDMF

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    ROQUETTE FRERES

    France
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    ROQUETTE FRERES

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    LYCADEX PF

    Registration Number : 222MF10150

    Registrant's Address : La Haute Loge LESTREM FRANCE

    Initial Date of Registration : 2010-05-17

    Latest Date of Registration : 2018-10-12

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    FINISHED DOSAGE FORMULATIONS

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    Dosage Form : INJECTABLE

    DEXTROSE MONOHYDRATE
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    PCHi
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    Dosage Form : INJECTABLE

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    DEXTROSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 5

    Potency Unit : %

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    Dosage Form : INJECTION

    DEXTROSE MONOHYDRATE
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    PCHi
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    Dosage Form : INJECTION

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    DEXTROSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 5.05

    Potency Unit : %

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    Dosage Form : SOLUTION, INJECTION

    DEXTROSE MONOHYDRATE
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    Dosage Form : SOLUTION, INJECTION

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    DEXTROSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 5

    Potency Unit : %

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    Dosage Form : SPRAY, METERED

    DEXTROSE MONOHYDRATE
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    PCHi
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    Dosage Form : SPRAY, METERED

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    PCHi
    Not Confirmed

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    DEXTROSE MONOHYDRATE

    Route : NASAL

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 5.5

    Potency Unit : %

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    Dosage Form : SUSPENSION

    DEXTROSE MONOHYDRATE
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    PCHi
    Not Confirmed

    Dosage Form : SUSPENSION

    USA
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    PCHi
    Not Confirmed

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    DEXTROSE MONOHYDRATE

    Route : NASAL

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 0

    Potency Unit : NA

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    06

    Dosage Form : TABLET, EXTENDED RELEASE

    DEXTROSE MONOHYDRATE
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    PCHi
    Not Confirmed

    Dosage Form : TABLET, EXTENDED RELEASE

    USA
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    PCHi
    Not Confirmed

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    DEXTROSE MONOHYDRATE

    Route : ORAL

    CAS : 77938-63-7

    UNII : LX22YL083G

    Potency Amount : 46.2

    Potency Unit : MG

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    EXCIPIENTS BY APPLICATIONS

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