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

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    01 BETAMETHASONE 17-VALERATE MICRONIZED (1)

    02 BUDESONIDE MICRONIZED (1)

    03 CLOBETASOL 17-PROPIONATE (1)

    04 DEFLAZACORT (1)

    05 DESONIDE MICRONIZED (1)

    06 DROSPIRENONE (1)

    07 DROSPIRENONE EP/USP (1)

    08 FLUTICASONE PROPIONATE MICRONIZED (1)

    09 METHYLPREDNISOLONE HEMISUCCINATE (1)

    10 MOMETASONE FUROATE MICRONIZED (1)

    11 NOMEGESTROL ACETATE (1)

    12 PREDNISOLONE SODIUM PHOSPHATE (1)

    13 TRIAMCINOLONE ACETONIDE MICRONIZED (1)

    14 ULIPRISTAL ACETATE (1)

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    01 Italy (14)

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    BETAMETHASONE 17-VALERATE MICRONIZE...

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    NEWCHEM SPA
    Inactive
    22406
    N/A
    2009-01-05
    II
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    BUDESONIDE MICRONIZED

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    NEWCHEM SPA
    Active
    25319
    Complete
    2013-11-19
    2013-09-03
    2011-08-22
    II
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    CLOBETASOL 17-PROPIONATE

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    NEWCHEM SPA
    Inactive
    22226
    N/A
    2008-11-20
    II
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    DEFLAZACORT

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    NEWCHEM SPA
    Active
    38357
    Complete
    2023-07-11
    2023-05-19
    2023-05-19
    II
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    DESONIDE MICRONIZED

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    NEWCHEM SPA
    Inactive
    22749
    N/A
    2009-04-21
    II
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    DROSPIRENONE

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    NEWCHEM SPA
    Active
    22802
    Complete
    2012-11-04
    2012-11-27
    2009-05-15
    II
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    DROSPIRENONE EP/USP

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    NEWCHEM SPA
    Active
    36709
    Complete
    2022-04-07
    2022-01-25
    2022-01-26
    II
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    FLUTICASONE PROPIONATE MICRONIZED

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    NEWCHEM SPA
    Active
    22236
    N/A
    2008-11-21
    II
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    METHYLPREDNISOLONE HEMISUCCINATE

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    NEWCHEM SPA
    Active
    22575
    N/A
    2009-02-26
    II
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    MOMETASONE FUROATE MICRONIZED

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    NEWCHEM SPA
    Active
    21993
    N/A
    2008-09-15
    II
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