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

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    01 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT (1)

    02 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT 95% POSITIONAL PURITY (1)

    03 5-ASA CRYSTALLIZED (1)

    04 AICA HYDROCHLORIDE (1)

    05 BUPROPION HCL FV3307 (1)

    06 BUPROPION HYDROCHLORIDE (1)

    07 CHE001-05 (BUPROPIONE HYDROBROMIDE) (1)

    08 DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE) (1)

    09 DIFLUNISAL (1)

    10 DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE) (1)

    11 DMPC STANDARD (1)

    12 DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLGLYCEROL) (1)

    13 DPPC (DIPALMITOYL-PHOSPHATATIDYLCHOLINE) (1)

    14 DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLINE) (1)

    15 EPTIFIBATIDE (1)

    16 ETODOLAC (1)

    17 FESOTERODINE FUMARATE (1)

    18 GIVINOSTAT HYDROCHLORIDE MONOHYDRATE (1)

    19 GOSERELIN ACETATE (1)

    20 HYDROXYZINE HCL.USP. XX 093082 (1)

    21 HYDROXYZINE PAMOATE USP. XX (1)

    22 INDOMETHACINE USP XX (1)

    23 LEUPROLIDE ACETATE (1)

    24 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PATRICA (FROSINONE)ITALY. (1)

    25 MESALAMINE CRYSTALLIZED, USP (1)

    26 MESALAMINE USP (1)

    27 MICONAZOLE BASE (1)

    28 MICONAZOLE NITRATE (1)

    29 NABUMETONE (1)

    30 OCTREOTIDE ACETATE (1)

    31 OXIRACETAM (1)

    32 PAROXETINE ACETATE (1)

    33 PENTAACETYLIOPAMIDOL INTERMEDIATE (1)

    34 POPC POSITIONAL PURITY 95% (1)

    35 POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHORYLCHOLINE) (1)

    36 SODIUM ALENDRONATE (1)

    37 SODIUM ALENDRONATE TRIHYDRATE (1)

    38 SODIUM IBANDRONATE MONOHYDRATE (1)

    39 STERILE WATER FOR INJECTION USP (1)

    40 TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS. (1)

    41 ZOLEDRONIC ACID HEMIPENTAHYDRATE (1)

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    01 CHEMI SPA (40)

    02 ITALFARMACO SPA (1)

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    01 Italy (41)

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    01 Active (11)

    02 Inactive (30)

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    01 Complete (3)

    02 Blank (38)

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    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...

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    CHEMI SPA
    Inactive
    14094
    N/A
    1999-04-23
    II
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    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...

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    CHEMI SPA
    Inactive
    14976
    N/A
    2000-07-28
    II
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    AICA HYDROCHLORIDE

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    CHEMI SPA
    Active
    14013
    N/A
    1999-03-05
    II
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    BUPROPION HCL FV3307

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    CHEMI SPA
    Active
    23208
    N/A
    2009-10-19
    II
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    BUPROPION HYDROCHLORIDE

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    CHEMI SPA
    Active
    11834
    N/A
    1996-01-29
    II
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    CHE001-05 (BUPROPIONE HYDROBROMIDE)

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    CHEMI SPA
    Active
    18922
    N/A
    2005-10-27
    II
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    DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3...

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    CHEMI SPA
    Inactive
    21381
    N/A
    2008-02-20
    II
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    DIFLUNISAL

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    CHEMI SPA
    Active
    7492
    N/A
    1988-05-22
    II
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    DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLI...

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    CHEMI SPA
    Inactive
    12998
    N/A
    1998-05-22
    II
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    DMPC STANDARD

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    CHEMI SPA
    Inactive
    13284
    N/A
    1998-10-20
    II
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