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    01 Alverine (1)

    02 Benzimidazole (1)

    03 Candesartan Cilexetil (1)

    04 Carglumic Acid (1)

    05 Carprofen (1)

    06 Chloropyramine (1)

    07 Clofedanol (1)

    08 Dimiracetam (1)

    09 Disopyramide (1)

    10 Divalproex Sodium (2)

    11 Efinaconazole (1)

    12 Embutramide (1)

    13 Fampridine (1)

    14 Felbamate (1)

    15 Gabapentin (1)

    16 Guanfacine (1)

    17 Iloperidone (1)

    18 Isopropamide Iodide (1)

    19 Istradefylline (1)

    20 Labetalol Hydrochloride (2)

    21 Landiolol Hydrochloride (1)

    22 Levosulpiride (1)

    23 Lofexidine (1)

    24 Lurasidone Hydrochloride (1)

    25 Memantine Hydrochloride (1)

    26 Midostaurin (1)

    27 Minodronic Acid (1)

    28 Nafronyl Oxalate (1)

    29 Naftopidil (1)

    30 Nalfurafine (1)

    31 Nimesulide (1)

    32 Orphenadrine (2)

    33 Orphenadrine Hydrochloride (1)

    34 Phenelzine Sulfate (1)

    35 Phenyltoloxamine Citrate (1)

    36 Pirfenidone (1)

    37 Pivagabine (1)

    38 Prenylamine Lactate (1)

    39 Proglumide (1)

    40 Propafenone Hydrochloride (1)

    41 Pyridostigmine (1)

    42 Ranolazine (1)

    43 Sivelestat Sodium Hydrate (1)

    44 Terfenadine (1)

    45 Thiaproline-M-Amino Benzoic Acid Hydrochloride (1)

    46 Trospium Chloride (1)

    47 Zonisamide (1)

    48 Blank (3)

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    01 Active (21)

    02 Inactive (19)

    03 Blank (13)

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    01 Valid (2)

    02 Blank (51)

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    01 217MF11129 (1)

    02 217MF11295 (1)

    03 218MF10992 (1)

    04 224MF10101 (1)

    05 225MF10161 (1)

    06 225MF10162 (1)

    07 227MF10007 (1)

    08 229MF10004 (1)

    09 229MF10035 (1)

    10 229MF10052 (1)

    11 304MF10033 (1)

    12 305MF10015 (1)

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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

    PDF Supplier PDF
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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

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    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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