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

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    01 CARBOPLATIN (1)

    02 CHLORHEXIDINE BASE (1)

    03 CHLORHEXIDINE GLUCONATE SOLUTION (1)

    04 CHLOROTHIAZIDE (1)

    05 CHLORPROPAMIDE (1)

    06 DACARBAZINE (1)

    07 FACILITY FOR AZITHROMICIN DIHYDRATE G. IN ZAGREB, YUGOSLAVIA (1)

    08 GLUTETHIMIDE (CHEM NAME: 2-ETHYL-2-PHENYL GLUTARIMIDE) (1)

    09 IRINOTECAN HYDROCHLORIDE TRIHYDRATE (1)

    10 KETOPROFEN (1)

    11 MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE (1)

    12 MECLIZINE HCL (1)

    13 MESALAZINE (1)

    14 METOPROLOL TARTRATE (1)

    15 OXALIPLATIN (1)

    16 OXYTETRACYCLINE (1)

    17 OXYTETRACYCLINE HYDROCHLORIDE (1)

    18 PEMOLINE (1)

    19 SULFISOXAZOLE (1)

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    01 PLIVA (1)

    02 PLIVA CROATIA LTD (4)

    03 PLIVA DD (2)

    04 PLIVA HRVATSKA DOO (1)

    05 PLIVA LACHEMA AS (1)

    06 PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRY (7)

    07 PLIVA-LACHEMA AS (3)

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    01 Croatia (19)

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    01 Active (2)

    02 Inactive (17)

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    01 Complete (1)

    02 Blank (18)

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    CARBOPLATIN

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    PLIVA-LACHEMA AS
    Inactive
    16280
    N/A
    2002-12-02
    II
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    CHLORHEXIDINE BASE

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    PLIVA PHARMACEUTICAL ...
    Inactive
    8349
    N/A
    1989-12-29
    II
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    CHLORHEXIDINE GLUCONATE SOLUTION

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    PLIVA PHARMACEUTICAL ...
    Inactive
    8363
    N/A
    1989-12-18
    II
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    CHLOROTHIAZIDE

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    PLIVA PHARMACEUTICAL ...
    Inactive
    4610
    N/A
    1982-06-16
    II
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    CHLORPROPAMIDE

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    PLIVA PHARMACEUTICAL ...
    Inactive
    2885
    N/A
    1977-03-17
    II
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    DACARBAZINE

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    PLIVA LACHEMA AS
    Inactive
    16326
    N/A
    2002-12-19
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    GLUTETHIMIDE (CHEM NAME: 2-ETHYL-...

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    PLIVA PHARMACEUTICAL ...
    Inactive
    4168
    N/A
    1981-05-07
    II
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    IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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    PLIVA-LACHEMA AS
    Active
    19050
    Complete
    2012-11-23
    2012-11-09
    2005-12-20
    II
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    KETOPROFEN

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    PLIVA PHARMACEUTICAL ...
    Inactive
    8551
    N/A
    1990-04-23
    II
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    MECLIZINE HCL

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    PLIVA PHARMACEUTICAL ...
    Inactive
    2847
    N/A
    1977-02-04
    II
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