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    01 1Biperiden Hydrochloride

    02 1Butorphanol Tartrate

    03 1Cyclosporine

    04 1Divalproex Sodium

    05 1Enflurane

    06 2Erythromycin

    07 1Erythromycin Ethyl Succinate

    08 1Erythromycin Stearate

    09 1Erythromycin Thiocyanate

    10 1Isoflurane

    11 1Paricalcitol

    12 1Ritonavir

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    01

    Cyclosporine

    U.S.A

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13800

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 1998-093 - Rev 07

    Issue Date : 2020-10-09

    Type : Chemical and TSE

    Substance Number : 994

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 0074-5503

    Start Marketing Date : 2010-05-24

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : AbbVie Korea Inc.

    Registration Date : 2005-08-31

    Registration Number : 20050831-18-C-100-05

    Manufacturer Name : AbbVie Inc.

    Manufacturer Address : 1401 Sheridan Road, North Chicago, IL, 60064-4000, USA

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    02

    Erythromycin

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13197

    Submission : 1998-04-30

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2016-267 - Rev 00

    Issue Date : 2022-03-14

    Type : Chemical

    Substance Number : 179

    Status : Valid

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    03

    Erythromycin

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-09

    Pay. Date : 2013-09-25

    DMF Number : 27155

    Submission : 2015-11-10

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 1997-001 - Rev 08

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 179

    Status : Valid

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    04

    Biperiden Hydrochloride

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    Certificate Number : R2-CEP 1995-038 - Rev 05

    Issue Date : 2019-01-24

    Type : Chemical

    Substance Number : 1074

    Status : Valid

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    05

    Butorphanol Tartrate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 8904

    Submission : 1990-12-20

    Status : Active

    Type : II

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    06

    Erythromycin Ethyl Succinate

    U.S.A

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13443

    Submission : 1998-09-01

    Status : Active

    Type : II

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    07

    Erythromycin Stearate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13372

    Submission : 1998-09-01

    Status : Active

    Type : II

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    08

    Isoflurane

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Certificate Number : R1-CEP 2006-292 - Rev 00

    Issue Date : 2012-09-24

    Type : Chemical

    Substance Number : 1673

    Status : Valid

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    09

    Paricalcitol

    U.S.A

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24315

    Submission : 2010-11-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 68513-1054

    Start Marketing Date : 2011-09-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

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    10

    Ritonavir

    U.S.A

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    Certificate Number : R1-CEP 2012-397 - Rev 00

    Issue Date : 2019-09-19

    Type : Chemical

    Substance Number : 2136

    Status : Valid

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