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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Chemi SpA

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    Chemi SpA
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    Italy
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    Via dei lavoratori 54, 20092 Cinisello Balsamo (Milano)
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    +39 02 6128431
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    • FDA
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    Leuprolide Acetate

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    USDMF

    Found USDMF

    14763
    Active
    LEUPROLIDE ACETATE
    2000-03-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-115 - Rev 04
    Valid
    Leuprorelin
    2022-03-10
    Japanese DMF

    Found JDMF

    224MF10177
    Leuprorelin acetate at Via dei Labo...
    2012-08-17
    Written Confirmation

    Close WC

    Application Number
    14763
    R1-CEP 2008-115 - Rev 04
    224MF10177
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPROLIDE ACETATE
    Leuprorelin
    Leuprorelin acetate at Via dei Labo...
    Issue/Submission Date
    2000-03-07
    2022-03-10
    2012-08-17
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    • FDA
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    Mesalazine

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    USDMF

    Caution USDMF

    9454
    Inactive
    TERMINAL STERILZATION PROGRAM IN ME...
    1991-12-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-046 - Rev 03
    Valid
    Mesalazine, Product codes: FV0945, ...
    2020-03-17
    Japanese DMF

    Found JDMF

    219MF10131
    Mesalazine at Via dei Laboratori 54...
    2007-04-18
    Written Confirmation

    Close WC

    Application Number
    9454
    R1-CEP 2008-046 - Rev 03
    219MF10131
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TERMINAL STERILZATION PROGRAM IN ME...
    Mesalazine, Product codes: FV0945, ...
    Mesalazine at Via dei Laboratori 54...
    Issue/Submission Date
    1991-12-09
    2020-03-17
    2007-04-18
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    • FDA
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    Nabumetone

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    USDMF

    Caution USDMF

    12296
    Inactive
    NABUMETONE
    1996-12-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-002 - Rev 01
    Valid
    Nabumetone, FV 4074
    2014-03-10
    Japanese DMF

    Found JDMF

    224MF10109
    Nabumetone at Viale dei Laboratori ...
    2012-06-22
    Written Confirmation

    Close WC

    Application Number
    12296
    R1-CEP 2007-002 - Rev 01
    224MF10109
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NABUMETONE
    Nabumetone, FV 4074
    Nabumetone at Viale dei Laboratori ...
    Issue/Submission Date
    1996-12-23
    2014-03-10
    2012-06-22
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    Mesalazine

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    USDMF

    Found USDMF

    11951
    Active
    MESALAMINE USP
    1996-04-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-188 - Rev 06
    Valid
    Mesalazine, Products codes: FV 0950...
    2020-03-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11951
    R1-CEP 2003-188 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP
    Mesalazine, Products codes: FV 0950...
    Issue/Submission Date
    1996-04-29
    2020-03-31
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    • FDA
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    Octreotide Acetate

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    USDMF

    Found USDMF

    19567
    Active
    OCTREOTIDE ACETATE
    2006-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10055
    Octreotide acetate "CHEMI" at Viale...
    2014-03-06
    Written Confirmation

    Close WC

    Application Number
    19567
    226MF10055
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OCTREOTIDE ACETATE
    Octreotide acetate "CHEMI" at Viale...
    Issue/Submission Date
    2006-06-28
    2014-03-06
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    • FDA
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    Goserelin Acetate

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    USDMF

    Caution USDMF

    17768
    Inactive
    GOSERELIN ACETATE
    2004-10-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-276 - Rev 02
    Valid
    Goserelin
    2017-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17768
    R1-CEP 2005-276 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GOSERELIN ACETATE
    Goserelin
    Issue/Submission Date
    2004-10-18
    2017-01-31
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    Zoledronic Acid

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    USDMF

    Caution USDMF

    25983
    Inactive
    ZOLEDRONIC ACID HEMIPENTAHYDRATE
    2012-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10022
    Zoledronic acid "CHEMI" at Viale de...
    2013-02-06
    Written Confirmation

    Close WC

    Application Number
    25983
    225MF10022
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZOLEDRONIC ACID HEMIPENTAHYDRATE
    Zoledronic acid "CHEMI" at Viale de...
    Issue/Submission Date
    2012-04-19
    2013-02-06
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    • FDA
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    1H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride

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    USDMF

    Found USDMF

    14013
    Active
    AICA HYDROCHLORIDE
    1999-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14013
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AICA HYDROCHLORIDE
    Issue/Submission Date
    1999-03-05
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    Bupropion Hydrobromide

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    USDMF

    Found USDMF

    18922
    Active
    CHE001-05 (BUPROPIONE HYDROBROMIDE)
    2005-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18922
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHE001-05 (BUPROPIONE HYDROBROMIDE)
    Issue/Submission Date
    2005-10-27
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    Bupropion Hydrochloride

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    USDMF

    Found USDMF

    11834
    Active
    BUPROPION HYDROCHLORIDE
    1996-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11834
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUPROPION HYDROCHLORIDE
    Issue/Submission Date
    1996-01-29
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    Bupropion Hydrochloride

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    USDMF

    Found USDMF

    23208
    Active
    BUPROPION HCL FV3307
    2009-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23208
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUPROPION HCL FV3307
    Issue/Submission Date
    2009-10-19
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    • FDA
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    Diflunisal

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    USDMF

    Found USDMF

    7492
    Active
    DIFLUNISAL
    1988-05-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7492
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIFLUNISAL
    Issue/Submission Date
    1988-05-22
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    Flunarizine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2013-035 - Rev 01
    Valid
    Flunarizine dihydrochloride
    2023-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2013-035 - Rev 01
    Status
    Valid
     
    Filing Details
    Flunarizine dihydrochloride
    Issue/Submission Date
    2023-10-13
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    • FDA
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    Givinostat

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    USDMF

    Found USDMF

    37344
    Active
    GIVINOSTAT HYDROCHLORIDE MONOHYDRAT...
    2023-04-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37344
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GIVINOSTAT HYDROCHLORIDE MONOHYDRAT...
    Issue/Submission Date
    2023-04-04
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    • FDA
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    Ibandronate Sodium

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    USDMF

    Found USDMF

    20427
    Active
    SODIUM IBANDRONATE MONOHYDRATE
    2007-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20427
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM IBANDRONATE MONOHYDRATE
    Issue/Submission Date
    2007-04-05
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    • FDA
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    Mesalazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25385
    Active
    MESALAMINE CRYSTALLIZED, USP
    2011-10-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25385
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MESALAMINE CRYSTALLIZED, USP
    Issue/Submission Date
    2011-10-13
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    • FDA
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    Paroxetine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-188 - Rev 02
    Valid
    Paroxetine hydrochloride hemihydrat...
    2020-06-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-188 - Rev 02
    Status
    Valid
     
    Filing Details
    Paroxetine hydrochloride hemihydrat...
    Issue/Submission Date
    2020-06-19
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    • FDA
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    Alendronate Sodium

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    USDMF

    Caution USDMF

    15858
    Inactive
    SODIUM ALENDRONATE
    2002-02-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15858
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM ALENDRONATE
    Issue/Submission Date
    2002-02-12
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    Alendronate Sodium

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    USDMF

    Caution USDMF

    19934
    Inactive
    SODIUM ALENDRONATE TRIHYDRATE
    2006-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19934
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM ALENDRONATE TRIHYDRATE
    Issue/Submission Date
    2006-11-03
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    • FDA
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    Diarachidonyl Phosphatidylcholine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21381
    Inactive
    DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3...
    2008-02-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21381
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3...
    Issue/Submission Date
    2008-02-20
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    • FDA
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    Dimyristoyl Lecithin

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    USDMF

    Caution USDMF

    12998
    Inactive
    DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLI...
    1998-05-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12998
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLI...
    Issue/Submission Date
    1998-05-22
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    Dimyristoyl Lecithin

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    USDMF

    Caution USDMF

    13284
    Inactive
    DMPC STANDARD
    1998-10-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13284
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DMPC STANDARD
    Issue/Submission Date
    1998-10-20
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    Dimyristoylphosphatidylglycerol

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    USDMF

    Caution USDMF

    13104
    Inactive
    DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLG...
    1998-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13104
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLG...
    Issue/Submission Date
    1998-07-31
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    Eptifibatide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24933
    Inactive
    EPTIFIBATIDE
    2011-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24933
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    EPTIFIBATIDE
    Issue/Submission Date
    2011-05-11
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    Etodolac

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11740
    Inactive
    ETODOLAC
    1995-11-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11740
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ETODOLAC
    Issue/Submission Date
    1995-11-06
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    Fesoterodine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    26498
    Inactive
    FESOTERODINE FUMARATE
    2012-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26498
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2012-09-28
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    Hydroxyzine Dihydrochloride

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    USDMF

    Caution USDMF

    4622
    Inactive
    HYDROXYZINE HCL.USP. XX 093082
    1982-08-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4622
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    HYDROXYZINE HCL.USP. XX 093082
    Issue/Submission Date
    1982-08-11
    ASK
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    Hydroxyzine Pamoate

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    USDMF

    Caution USDMF

    4629
    Inactive
    HYDROXYZINE PAMOATE USP. XX
    1982-08-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4629
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    HYDROXYZINE PAMOATE USP. XX
    Issue/Submission Date
    1982-08-11
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    Indomethacin

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    USDMF

    Caution USDMF

    4394
    Inactive
    INDOMETHACINE USP XX
    1982-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    4394
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    INDOMETHACINE USP XX
    Issue/Submission Date
    1982-01-18
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    Iopamidol

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    USDMF

    Caution USDMF

    12229
    Inactive
    PENTAACETYLIOPAMIDOL INTERMEDIATE
    1996-11-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12229
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PENTAACETYLIOPAMIDOL INTERMEDIATE
    Issue/Submission Date
    1996-11-13
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    Miconazole

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    USDMF

    Caution USDMF

    9648
    Inactive
    MICONAZOLE BASE
    1992-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    9648
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MICONAZOLE BASE
    Issue/Submission Date
    1992-04-16
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    Miconazole Nitrate

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    USDMF

    Caution USDMF

    9540
    Inactive
    MICONAZOLE NITRATE
    1992-02-10
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    9540
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MICONAZOLE NITRATE
    Issue/Submission Date
    1992-02-10
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    Oxiracetam

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    USDMF

    Caution USDMF

    8272
    Inactive
    OXIRACETAM
    1989-10-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    8272
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXIRACETAM
    Issue/Submission Date
    1989-10-24
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    POPC

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    USDMF

    Caution USDMF

    15498
    Inactive
    POPC POSITIONAL PURITY 95%
    2001-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    15498
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    POPC POSITIONAL PURITY 95%
    Issue/Submission Date
    2001-06-22
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    POPG

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    USDMF

    Caution USDMF

    14094
    Inactive
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    1999-04-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    14094
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    Issue/Submission Date
    1999-04-23
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    POPG

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    USDMF

    Caution USDMF

    14976
    Inactive
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    2000-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14976
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    Issue/Submission Date
    2000-07-28
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    Ypo0Ntk49O

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    USDMF

    Caution USDMF

    15463
    Inactive
    PAROXETINE ACETATE
    2001-05-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    15463
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PAROXETINE ACETATE
    Issue/Submission Date
    2001-05-29
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    8203
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1989-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    8203
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1989-09-07
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    5-ASA CRYSTALLIZED

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    USDMF

    Caution USDMF

    11952
    Inactive
    5-ASA CRYSTALLIZED
    1996-05-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    11952
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    5-ASA CRYSTALLIZED
    Issue/Submission Date
    1996-05-02
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    DPPC (DIPALMITOYL-PHOSPHATATIDYLCHOLINE)

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    USDMF

    Caution USDMF

    12717
    Inactive
    DPPC (DIPALMITOYL-PHOSPHATATIDYLCHO...
    1997-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    12717
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DPPC (DIPALMITOYL-PHOSPHATATIDYLCHO...
    Issue/Submission Date
    1997-10-21
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    DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLINE)

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    USDMF

    Caution USDMF

    13912
    Inactive
    DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLI...
    1998-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    13912
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLI...
    Issue/Submission Date
    1998-12-23
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    POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHORYLCHOLIN...

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    USDMF

    Caution USDMF

    14527
    Inactive
    POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCER...
    1999-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    14527
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCER...
    Issue/Submission Date
    1999-11-09
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    Benserazide Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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