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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Iwaki Seiyaku to the U.S. FDA. Original Data : FDA Website

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    01 CETIRIZINE HYDROCHLORIDE (1)

    02 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE SHIZUOKA FACTORY IN SHIZUOKA, JAPAN (1)

    03 PHENYLEPHRINE HCL (1)

    04 PILOCARPINE HYDROCHLORIDE (1)

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    01 IWAKI SEIYAKU CO LTD (2)

    02 SPERA NEXUS INC (2)

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    01 Japan (4)

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    CETIRIZINE HYDROCHLORIDE

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    IWAKI SEIYAKU CO LTD
    Inactive
    21864
    N/A
    2008-08-05
    II
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    PHENYLEPHRINE HCL

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    SPERA NEXUS INC
    Active
    8140
    Complete
    2013-06-24
    2013-06-12
    1989-07-07
    II
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    PILOCARPINE HYDROCHLORIDE

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    SPERA NEXUS INC
    Active
    12388
    Complete
    2017-06-16
    2017-05-17
    1997-02-21
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    IWAKI SEIYAKU CO LTD
    Inactive
    12387
    N/A
    1997-02-21
    II
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