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    Procos
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    Italy
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    via G. Matteotti, 249, 28062 Cameri (Novara)
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    +39.0321.64.22.11
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    Clofedanol

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    USDMF

    Found USDMF

    22902
    Active
    CHLOPHEDIANOL HYDROCHLORIDE
    2009-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11129
    Clofedanol Hydrochloride at Via Mat...
    2005-12-05
    Written Confirmation

    Close WC

    Application Number
    22902
    217MF11129
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLOPHEDIANOL HYDROCHLORIDE
    Clofedanol Hydrochloride at Via Mat...
    Issue/Submission Date
    2009-06-25
    2005-12-05
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    Efinaconazole

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    USDMF

    Found USDMF

    31933
    Active
    EFINACONAZOLE
    2017-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10015
    Efinaconazole at Via Matteotti 249,...
    2023-02-02
    Written Confirmation

    Close WC

    Application Number
    31933
    305MF10015
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EFINACONAZOLE
    Efinaconazole at Via Matteotti 249,...
    Issue/Submission Date
    2017-11-15
    2023-02-02
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    Labetalol Hydrochloride

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    USDMF

    Found USDMF

    10918
    Active
    LABETALOL HCl
    1994-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10101
    Labetalol hydrochloride GR at Via M...
    2012-05-25
    Written Confirmation

    Close WC

    Application Number
    10918
    224MF10101
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LABETALOL HCl
    Labetalol hydrochloride GR at Via M...
    Issue/Submission Date
    1994-06-08
    2012-05-25
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    Memantine Hydrochloride

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    USDMF

    Found USDMF

    26269
    Active
    MEMANTINE HYDROCHLORIDE
    2012-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10004
    Memantine hydrochloride at Via Matt...
    2017-01-10
    Written Confirmation

    Close WC

    Application Number
    26269
    229MF10004
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEMANTINE HYDROCHLORIDE
    Memantine hydrochloride at Via Matt...
    Issue/Submission Date
    2012-07-30
    2017-01-10
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    Pirfenidone

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    USDMF

    Found USDMF

    31815
    Active
    PIRFENIDONE
    2017-07-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-073 - Rev 00
    Valid
    Pirfenidone
    2021-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31815
    R0-CEP 2020-073 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Issue/Submission Date
    2017-07-31
    2021-10-28
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    Propafenone Hydrochloride

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    USDMF

    Found USDMF

    11426
    Active
    PROPAFENONE HYDROCHLORIDE
    1995-04-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11295
    Hydrochloric acid propafenone at Vi...
    2005-12-22
    Written Confirmation

    Close WC

    Application Number
    11426
    217MF11295
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PROPAFENONE HYDROCHLORIDE
    Hydrochloric acid propafenone at Vi...
    Issue/Submission Date
    1995-04-03
    2005-12-22
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    Pyridostigmine

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    USDMF

    Found USDMF

    16035
    Active
    PYRIDOSTIGMINE BROMIDE
    2002-06-26
    CEP/COS

    Found CEP/COS

    CEP 2009-211 - Rev 01
    Valid
    Pyridostigmine bromide
    2023-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16035
    CEP 2009-211 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PYRIDOSTIGMINE BROMIDE
    Pyridostigmine bromide
    Issue/Submission Date
    2002-06-26
    2023-11-17
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    Candesartan Cilexetil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10007
    Candesartan cilexetil at Via Matteo...
    2015-01-05
    Written Confirmation

    Close WC

    Application Number
    227MF10007
    Status
     
    Filing Details
    Candesartan cilexetil at Via Matteo...
    Issue/Submission Date
    2015-01-05
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    Carglumic Acid

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    USDMF

    Found USDMF

    38477
    Active
    CARGLUMIC ACID
    2023-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38477
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARGLUMIC ACID
    Issue/Submission Date
    2023-07-12
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    Embutramide

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    USDMF

    Found USDMF

    11004
    Active
    EMBUTRAMIDE
    1994-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11004
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EMBUTRAMIDE
    Issue/Submission Date
    1994-07-21
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    Fampridine

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    USDMF

    Found USDMF

    27647
    Active
    DALFAMPRIDINE
    2013-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27647
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALFAMPRIDINE
    Issue/Submission Date
    2013-10-15
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    Felbamate

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    USDMF

    Found USDMF

    21247
    Active
    FELBAMATE
    2008-01-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21247
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FELBAMATE
    Issue/Submission Date
    2008-01-14
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    Guanfacine

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    USDMF

    Found USDMF

    28312
    Active
    GUANFACINE HYDROCHLORIDE
    2014-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28312
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GUANFACINE HYDROCHLORIDE
    Issue/Submission Date
    2014-05-19
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    Iloperidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26945
    Active
    ILOPERIDONE
    2013-03-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26945
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ILOPERIDONE
    Issue/Submission Date
    2013-03-04
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    Istradefylline

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38212
    Active
    ISTRADEFYLLINE
    2023-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38212
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ISTRADEFYLLINE
    Issue/Submission Date
    2023-04-12
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    Labetalol Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10992
    Labetalol hydrochloride at Via Matt...
    2006-12-18
    Written Confirmation

    Close WC

    Application Number
    218MF10992
    Status
     
    Filing Details
    Labetalol hydrochloride at Via Matt...
    Issue/Submission Date
    2006-12-18
    ASK
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    Landiolol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10033
    Landiolol Hydrochloride at Via Matt...
    2022-02-10
    Written Confirmation

    Close WC

    Application Number
    304MF10033
    Status
     
    Filing Details
    Landiolol Hydrochloride at Via Matt...
    Issue/Submission Date
    2022-02-10
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    Lofexidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37543
    Active
    LOFEXIDINE HYDROCHLORIDE
    2022-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37543
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LOFEXIDINE HYDROCHLORIDE
    Issue/Submission Date
    2022-10-25
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    Lurasidone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33872
    Active
    LURASIDONE HYDROCHLORIDE
    2019-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33872
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2019-06-05
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    Midostaurin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35281
    Active
    MIDOSTAURIN
    2020-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35281
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MIDOSTAURIN
    Issue/Submission Date
    2020-11-20
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    Minodronic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10035
    Minodronic acid hydrate at Via Matt...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    229MF10035
    Status
     
    Filing Details
    Minodronic acid hydrate at Via Matt...
    Issue/Submission Date
    2017-02-08
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    Naftopidil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10162
    Naftopidil at Via Matteotti 249,280...
    2013-08-14
    Written Confirmation

    Close WC

    Application Number
    225MF10162
    Status
     
    Filing Details
    Naftopidil at Via Matteotti 249,280...
    Issue/Submission Date
    2013-08-14
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    Nalfurafine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10052
    Nalfurafine hydrochloride salt at V...
    2017-02-22
    Written Confirmation

    Close WC

    Application Number
    229MF10052
    Status
     
    Filing Details
    Nalfurafine hydrochloride salt at V...
    Issue/Submission Date
    2017-02-22
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    Orphenadrine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14971
    Active
    ORPHENADRINE CITRATE
    2000-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14971
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ORPHENADRINE CITRATE
    Issue/Submission Date
    2000-07-19
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    Phenelzine Sulfate

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    USDMF

    Found USDMF

    4328
    Active
    PHENELZINE SULFATE
    1981-10-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4328
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHENELZINE SULFATE
    Issue/Submission Date
    1981-10-02
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    Phenyltoloxamine Citrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    2938
    Active
    PHENYLTOLOXAMINE CITRATE
    1977-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2938
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHENYLTOLOXAMINE CITRATE
    Issue/Submission Date
    1977-05-09
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    Sivelestat Sodium Hydrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10161
    Sivelestat sodium hydrate at Via Ma...
    2013-08-14
    Written Confirmation

    Close WC

    Application Number
    225MF10161
    Status
     
    Filing Details
    Sivelestat sodium hydrate at Via Ma...
    Issue/Submission Date
    2013-08-14
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    Trospium Chloride

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    USDMF

    Found USDMF

    22079
    Active
    TROSPIUM CHLORIDE
    2008-10-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22079
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TROSPIUM CHLORIDE
    Issue/Submission Date
    2008-10-08
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    Alverine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    29917
    Inactive
    ALVERINE CITRATE
    2015-10-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    29917
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALVERINE CITRATE
    Issue/Submission Date
    2015-10-06
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    Benzimidazole

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    USDMF

    Caution USDMF

    15105
    Inactive
    1-(4- FLUOROBENZYL)-2-CHLOROBENZIMI...
    2000-10-13
    CEP/COS

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    Japanese DMF

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    Application Number
    15105
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    1-(4- FLUOROBENZYL)-2-CHLOROBENZIMI...
    Issue/Submission Date
    2000-10-13
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    Dimiracetam

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    USDMF

    Caution USDMF

    25123
    Inactive
    DIMIRACETAM
    2011-07-11
    CEP/COS

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    Application Number
    25123
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIMIRACETAM
    Issue/Submission Date
    2011-07-11
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    Disopyramide

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    USDMF

    Caution USDMF

    5724
    Inactive
    DISOPYRAMIDE PHOSPHATE
    1985-02-14
    CEP/COS

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    Application Number
    5724
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DISOPYRAMIDE PHOSPHATE
    Issue/Submission Date
    1985-02-14
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    Divalproex Sodium

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    USDMF

    Caution USDMF

    4380
    Inactive
    VALPROIC ACID
    1981-10-26
    CEP/COS

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    Application Number
    4380
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    VALPROIC ACID
    Issue/Submission Date
    1981-10-26
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    Divalproex Sodium

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    USDMF

    Caution USDMF

    17349
    Inactive
    DIVALPROEX SODIUM
    2004-05-03
    CEP/COS

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    Application Number
    17349
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIVALPROEX SODIUM
    Issue/Submission Date
    2004-05-03
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    Gabapentin

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    USDMF

    Caution USDMF

    16342
    Inactive
    GABAPENTIN
    2002-12-30
    CEP/COS

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    Japanese DMF

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    Application Number
    16342
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GABAPENTIN
    Issue/Submission Date
    2002-12-30
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    Isopropamide Iodide

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    USDMF

    Caution USDMF

    2935
    Inactive
    ISOPROPAMIDE IODIDE
    1977-05-09
    CEP/COS

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    Application Number
    2935
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ISOPROPAMIDE IODIDE
    Issue/Submission Date
    1977-05-09
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    Nimesulide

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    USDMF

    Caution USDMF

    15566
    Inactive
    NIMESULIDE
    2001-07-24
    CEP/COS

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    Japanese DMF

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    Application Number
    15566
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NIMESULIDE
    Issue/Submission Date
    2001-07-24
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    Orphenadrine

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    USDMF

    Caution USDMF

    2942
    Inactive
    ORPHENADRINE HYROCHLORIDE & ORPHENA...
    1977-05-09
    CEP/COS

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    Application Number
    2942
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ORPHENADRINE HYROCHLORIDE & ORPHENA...
    Issue/Submission Date
    1977-05-09
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    Pivagabine

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    USDMF

    Caution USDMF

    21796
    Inactive
    PIVAGABINE
    2008-07-09
    CEP/COS

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    Application Number
    21796
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PIVAGABINE
    Issue/Submission Date
    2008-07-09
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    Prenylamine Lactate

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    USDMF

    Caution USDMF

    3553
    Inactive
    PRENILAMINE LACTATE
    1979-07-03
    CEP/COS

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    Application Number
    3553
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PRENILAMINE LACTATE
    Issue/Submission Date
    1979-07-03
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    Proglumide

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    USDMF

    Caution USDMF

    3745
    Inactive
    PROGLUMIDE
    1980-03-07
    CEP/COS

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    Application Number
    3745
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PROGLUMIDE
    Issue/Submission Date
    1980-03-07
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    Terfenadine

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    USDMF

    Caution USDMF

    9038
    Inactive
    TERFENADINE
    1991-03-29
    CEP/COS

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    Application Number
    9038
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERFENADINE
    Issue/Submission Date
    1991-03-29
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    Thiaproline-M-Amino Benzoic Acid Hydrochloride

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    USDMF

    Caution USDMF

    15081
    Inactive
    THIAPROLINE-M-AMINO BENZOIC ACID HY...
    2000-10-05
    CEP/COS

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    Japanese DMF

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    Application Number
    15081
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    THIAPROLINE-M-AMINO BENZOIC ACID HY...
    Issue/Submission Date
    2000-10-05
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    Zonisamide

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    USDMF

    Caution USDMF

    17254
    Inactive
    ZONISAMIDE
    2004-03-26
    CEP/COS

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    Application Number
    17254
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZONISAMIDE
    Issue/Submission Date
    2004-03-26
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    PERSONNEL, FACILS AND GEN OPERATING PROCEDURES

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    USDMF

    Caution USDMF

    4781
    Inactive
    PERSONNEL, FACILS AND GEN OPERATING...
    1983-01-11
    CEP/COS

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    Japanese DMF

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    Application Number
    4781
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PERSONNEL, FACILS AND GEN OPERATING...
    Issue/Submission Date
    1983-01-11
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    MONOALDEHYDE

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    USDMF

    Caution USDMF

    14748
    Inactive
    MONOALDEHYDE
    2000-03-02
    CEP/COS

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    Application Number
    14748
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MONOALDEHYDE
    Issue/Submission Date
    2000-03-02
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    OXO ACID DIPA SALT

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    USDMF

    Caution USDMF

    21159
    Inactive
    OXO ACID DIPA SALT
    2007-11-26
    CEP/COS

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    Application Number
    21159
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXO ACID DIPA SALT
    Issue/Submission Date
    2007-11-26
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    Carprofen

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    USDMF

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    CEP/COS

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Chloropyramine

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    USDMF

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    CEP/COS

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    Levosulpiride

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    USDMF

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    CEP/COS

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