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    01 1-Palmitoyl-2-Oleoyl-Sn-Glycero-3-Phosphocholine (1)

    02 7-Amino Cephalosporanic Acid (1)

    03 Afamelanotide (1)

    04 Amoxicillin Trihydrate (1)

    05 Ampicillin (1)

    06 Ampicillin Trihydrate (1)

    07 Aztreonam (1)

    08 Balsalazide Disodium (1)

    09 Benzoyl Peroxide (1)

    10 Benzphetamine (1)

    11 Bethanechol (1)

    12 Bisoprolol Fumarate (1)

    13 Bufexamac (1)

    14 Buserelin Acetate (1)

    15 Carbadox (1)

    16 Carbamazepine (1)

    17 Cefadroxil (1)

    18 Cefepime Hydrochloride (1)

    19 Cephapirin Benzathine (1)

    20 Cephapirin Sodium (1)

    21 Cetrorelix Acetate (1)

    22 Chlorthalidone (1)

    23 Choline Fenofibrate (1)

    24 Ciclopirox (1)

    25 Cimetidine (1)

    26 Cimetidine Hydrochloride (1)

    27 Clotrimazole (1)

    28 DPPC (1)

    29 DSPC (1)

    30 Desipramine Hydrochloride (1)

    31 Diclofenac Potassium (1)

    32 Diclofenac Sodium (1)

    33 Doxylamine Succinate (1)

    34 Eptifibatide (1)

    35 Fenofibrate (2)

    36 Glatiramer Acetate (1)

    37 Glucagon (1)

    38 Guanethidine (1)

    39 Imipramine (1)

    40 Imipramine Hydrochloride (1)

    41 L-Alpha-Distearoyl Phosphatidic Acid Sodium Salt (1)

    42 L-Arginine (2)

    43 Larazotide Acetate (1)

    44 Linaclotide (1)

    45 Lutetium Chloride Lu-177 (1)

    46 Mesalazine (2)

    47 Metaxalone (1)

    48 Methyldopa (1)

    49 Metronidazole (2)

    50 Miconazole (1)

    51 Miconazole Nitrate (1)

    52 Nafarelin Acetate (1)

    53 Nafcillin Sodium (1)

    54 Naproxen (1)

    55 Naproxen Sodium (1)

    56 Nebivolol (1)

    57 Olsalazine (1)

    58 Omiganan Pentahydrochloride (1)

    59 Oxacillin Sodium (1)

    60 Oxaprozin (1)

    61 Oxcarbazepine (1)

    62 Oxybutynin Hydrochloride (1)

    63 Oxytocin (1)

    64 POPG (1)

    65 Paclitaxel (1)

    66 Phentolamine Mesylate (1)

    67 Piperacillin Sodium (1)

    68 Piracetam (1)

    69 Quetiapine Hemifumarate (1)

    70 Ranitidine Hydrochloride (1)

    71 Secnidazole (1)

    72 Sulfasalazine (1)

    73 Sulfiram (1)

    74 Tetrabenazine (1)

    75 Tinidazole (1)

    76 Tizanidine HCl (1)

    77 Triamterene (2)

    78 Tribenoside (1)

    79 Trimethobenzamide HCl (1)

    80 Unii-856Lu0Gv8H (1)

    81 Valganciclovir Hydrochloride (1)

    82 Vapreotide (1)

    83 [3-[2,3-Dihydroxypropoxy(hydroxy)phosphoryl]oxy-2-tetradecanoyloxypropyl] tetradecanoate;sodium (1)

    84 Blank (5)

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    01 Active (33)

    02 Inactive (48)

    03 Blank (12)

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    01 Valid (8)

    02 Withdrawn by Holder (6)

    03 Blank (79)

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    01 218MF10511 (1)

    02 218MF10882 (1)

    03 218MF10886 (1)

    04 219MF10206 (1)

    05 219MF10225 (1)

    06 220MF10104 (1)

    07 222MF10028 (1)

    08 222MF10157 (1)

    09 224MF10075 (1)

    10 224MF10121 (1)

    11 225MF10037 (1)

    12 228MF10166 (1)

    13 231MF10090 (1)

    14 Blank (80)

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    01 Blank (93)

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    • FDA
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    Fenofibrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12078
    Active
    FENOFIBRATE
    1996-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-314 - Rev 02
    Valid
    Fenofibrate
    2018-01-29
    Japanese DMF

    Found JDMF

    222MF10028
    fenofibrate at 47, rue de Longvic B...
    2010-01-26
    Written Confirmation

    Close WC

    Application Number
    12078
    R1-CEP 2001-314 - Rev 02
    222MF10028
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FENOFIBRATE
    Fenofibrate
    fenofibrate at 47, rue de Longvic B...
    Issue/Submission Date
    1996-08-05
    2018-01-29
    2010-01-26
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    Metronidazole

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    USDMF

    Found USDMF

    3609
    Active
    METRONIDAZOLE USP
    1979-09-03
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-052 - Rev 02
    Valid
    Metronidazole
    2018-04-25
    Japanese DMF

    Found JDMF

    220MF10104
    METRONIDAZOLE at Via Bergamo, 121, ...
    2008-04-11
    Written Confirmation

    Close WC

    Application Number
    3609
    R2-CEP 1995-052 - Rev 02
    220MF10104
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METRONIDAZOLE USP
    Metronidazole
    METRONIDAZOLE at Via Bergamo, 121, ...
    Issue/Submission Date
    1979-09-03
    2018-04-25
    2008-04-11
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    Bisoprolol Fumarate

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    USDMF

    Found USDMF

    13910
    Active
    BISOPROLOL FUMARATE
    1998-12-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-143 - Rev 01
    Valid
    Bisoprolol fumarate
    2018-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13910
    R1-CEP 2008-143 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BISOPROLOL FUMARATE
    Bisoprolol fumarate
    Issue/Submission Date
    1998-12-22
    2018-01-29
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    18077
    Active
    CETRORELIX ACETATE BULK DRUG SUBSTA...
    2005-02-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10121
    Cetrorelix acetate at 310, Rue de R...
    2012-07-04
    Written Confirmation

    Close WC

    Application Number
    18077
    224MF10121
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CETRORELIX ACETATE BULK DRUG SUBSTA...
    Cetrorelix acetate at 310, Rue de R...
    Issue/Submission Date
    2005-02-11
    2012-07-04
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    Linaclotide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24992
    Active
    LINACLOTIDE
    2011-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10090
    Linaclotide at 2075 North 55th Stre...
    2019-04-16
    Written Confirmation

    Close WC

    Application Number
    24992
    231MF10090
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LINACLOTIDE
    Linaclotide at 2075 North 55th Stre...
    Issue/Submission Date
    2011-05-27
    2019-04-16
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    Mesalazine

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    USDMF

    Found USDMF

    11807
    Active
    MESALAMINE
    1996-01-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-243 - Rev 03
    Valid
    Mesalazine
    2018-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11807
    R1-CEP 2003-243 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE
    Mesalazine
    Issue/Submission Date
    1996-01-15
    2018-03-29
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    Oxybutynin Hydrochloride

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    USDMF

    Found USDMF

    12309
    Active
    OXYBUTYNIN HYDROCHLORIDE
    1997-01-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-200 - Rev 03
    Valid
    Oxybutynin hydrochloride
    2018-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12309
    R1-CEP 2001-200 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXYBUTYNIN HYDROCHLORIDE
    Oxybutynin hydrochloride
    Issue/Submission Date
    1997-01-09
    2018-01-29
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    Tetrabenazine

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    USDMF

    Found USDMF

    16683
    Active
    TETRABENAZINE
    2003-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10075
    Tetrabenazine at 47, rue de Longvic...
    2012-04-08
    Written Confirmation

    Close WC

    Application Number
    16683
    224MF10075
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TETRABENAZINE
    Tetrabenazine at 47, rue de Longvic...
    Issue/Submission Date
    2003-07-03
    2012-04-08
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    Naproxen

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    USDMF

    Caution USDMF

    11828
    Inactive
    NAPROXEN USP
    1996-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-081 - Rev 07
    Valid
    Naproxen
    2018-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11828
    R1-CEP 1996-081 - Rev 07
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NAPROXEN USP
    Naproxen
    Issue/Submission Date
    1996-01-26
    2018-05-17
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    1-Palmitoyl-2-Oleoyl-Sn-Glycero-3-Phosphocholine

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    USDMF

    Found USDMF

    14694
    Active
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    2000-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14694
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    Issue/Submission Date
    2000-02-15
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