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

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    01 ATOVAQUONE USP (1)

    02 ATROPINE SULFATE USP (1)

    03 ATROPINE USP (1)

    04 DOLASETRON MESYLATE (1)

    05 LORATADINE USP (1)

    06 MANUFACTURING SITES, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ZARAGOZA, SPAIN (1)

    07 PALONOSETRON HYDROCHLORIDE (1)

    08 TETRABENAZINE (1)

    09 TRANDOLAPRIL (1)

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    01 ROLABO OUTSOURCING SL (8)

    02 ROLABO SL (1)

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    01 Spain (9)

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    01 Active (6)

    02 Inactive (3)

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    01 Complete (5)

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    ATOVAQUONE USP

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    ROLABO OUTSOURCING SL
    Inactive
    21360
    N/A
    2008-02-15
    II
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    ATROPINE SULFATE USP

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    ROLABO OUTSOURCING SL
    Active
    29396
    Complete
    2015-11-06
    2015-05-22
    2015-05-25
    II
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    ATROPINE USP

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    ROLABO OUTSOURCING SL
    Active
    29521
    Complete
    2015-12-23
    2015-09-22
    2015-09-25
    II
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    DOLASETRON MESYLATE

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    ROLABO OUTSOURCING SL
    Inactive
    21852
    N/A
    2008-07-31
    II
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    LORATADINE USP

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    ROLABO OUTSOURCING SL
    Active
    14155
    Complete
    2015-05-26
    2014-07-02
    1999-05-26
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    PALONOSETRON HYDROCHLORIDE

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    ROLABO OUTSOURCING SL
    Active
    24497
    Complete
    2014-05-20
    2014-03-10
    2010-12-23
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    TETRABENAZINE

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    ROLABO OUTSOURCING SL
    Active
    29828
    Complete
    2016-01-06
    2015-10-06
    2015-10-09
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    TRANDOLAPRIL

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    ROLABO OUTSOURCING SL
    Active
    18947
    N/A
    2005-11-08
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    MANUFACTURING SITES, FACILITIES, PE...

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    ROLABO SL
    Inactive
    12351
    N/A
    1997-02-02
    II
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