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    01 1Acamprosate Calcium

    02 1Aceclofenac

    03 1Alpha/Beta-Arteether

    04 1Amisulpride

    05 1Amitriptyline Hydrochloride

    06 1Amlodipine Besylate

    07 1Amorolfine Hydrochloride

    08 1Anastrozole

    09 1Aripiprazole

    10 1Artesunate

    11 1Ascorbic Acid

    12 1Aspirin

    13 1Atenolol

    14 1Atorvastatin

    15 1Benfotiamine

    16 1Bicalutamide

    17 1Bisoprolol Fumarate

    18 1Bortezomib

    19 1Buclizine Hydrochloride

    20 1Bupropion Hydrochloride

    21 1CEFCAPENE PIVOXIL HYDROCHLORIDE HYDRATE

    22 1Calcium Glycerophosphate

    23 1Camylofin Dihydrochloride

    24 1Capecitabine

    25 1Carbamazepine

    26 1Carbidopa

    27 1Carboplatin

    28 1Carvedilol

    29 1Cefaclor

    30 1Cefdinir

    31 1Cefditoren Pivoxil

    32 1Cefetamet Pivoxil Hydrochloride

    33 1Cefixime

    34 1Cefpodoxime Proxetil

    35 1Cefprozil

    36 1Cefuroxime Axetil

    37 1Cephalexin Monohydrate

    38 1Cetirizine Dihydrochloride

    39 1Chlorpromazine Hydrochloride

    40 1Cilnidipine

    41 1Cinitapride Hydrogen Tartrate

    42 1Cinnarizine

    43 1Cisplatin

    44 1Citalopram Hydrobromide

    45 1Clomiphene Citrate

    46 1Clomipramine Hydrochloride

    47 1Clonazepam

    48 1Clonidine

    49 1Cyclophosphamide

    50 1Dapoxetine Hydrochloride

    51 1Desvenlafaxine Succinate

    52 1Dextromethorphan Hydrobromide

    53 1Diacerein

    54 1Diclofenac Potassium

    55 1Diclofenac Sodium

    56 1Dihydroartemisinin Methyl Ether

    57 1Diltiazem Hydrochloride

    58 1Domperidone

    59 1Domperidone Maleate

    60 1Dosulepin HCl

    61 1Doxapram Hydrochloride

    62 1Doxofylline

    63 1Doxylamine Succinate

    64 1Duloxetine Hydrochloride

    65 1Ebastine

    66 1Eberconazole

    67 1Erlotinib

    68 1Escitalopram Oxalate

    69 1Etizolam

    70 1Etodolac

    71 1Etoricoxib

    72 1Ezetimibe

    73 1Fenpiverinium Bromide

    74 1Fexofenadine Hydrochloride

    75 1Finasteride

    76 1Fluconazole

    77 1Flupentixol Dihydrochloride

    78 1Flurbiprofen

    79 1Folic Acid

    80 1Gabapentin

    81 1Gefitinib

    82 1Gemcitabine

    83 1Glibenclamide

    84 1Glimepiride

    85 1Glycopyrronium Bromide

    86 1Granisetron Hydrochloride

    87 1Halobetasol

    88 1Hydrochlorothiazide

    89 1Hydroxyurea

    90 1Ibuprofen

    91 1Imatinib Mesylate

    92 1Imipramine Hydrochloride

    93 1Iron Sucrose

    94 1Isotretinoin

    95 1Itraconazole

    96 1Ketorolac Trometamol

    97 1Leflunomide

    98 1Letrozole

    99 1Levetiracetam

    100 1Levoamlodipine

    101 1Levocetirizine Dihydrochloride

    102 1Levosulpiride

    103 1Lidocaine

    104 1Lidocaine Hydrochloride

    105 1Lorazepam

    106 1Losartan Potassium

    107 1Loteprednol Etabonate

    108 1Luliconazole

    109 1Meclizine Hydrochloride

    110 1Mefenamic Acid

    111 1Melitracen Hydrochloride

    112 1Meloxicam

    113 1Memantine Hydrochloride

    114 1Methylcobalamin

    115 1Metoprolol Succinate

    116 1Metoprolol Tartrate

    117 1Metronidazole

    118 1Misoprostol

    119 1Modafinil

    120 1Moxifloxacin Hydrochloride

    121 1Naproxen

    122 1Naproxen Sodium

    123 1Nortriptyline

    124 1Olmesartan Medoxomil

    125 1Ondansetron

    126 1Ondansetron Hydrochloride

    127 1Ornidazole

    128 1Orphenadrine

    129 1Otilonium Bromide

    130 1Oxaliplatin

    131 1Oxethazaine

    132 1Oxolamine Citrate

    133 1Oxolamine Phosphate

    134 1Pantoprazole Sodium

    135 1Phenylephrine Hydrochloride

    136 1Pyrimethamine

    137 1Racecadotril

    138 1Ranolazine

    139 1Rivastigmine

    140 1Rivastigmine Tartrate

    141 1Rosuvastatin Calcium

    142 1Sertaconazole Nitrate

    143 1Silodosin

    144 1Sodium Picosulfate

    145 1Sparfloxacin

    146 1Tamoxifen Citrate

    147 1Telmisartan

    148 1Teneligliptin Hydrobromide

    149 1Terbinafine Hydrochloride

    150 1Thiocolchicoside

    151 1Tizanidine Hydrochloride

    152 1Topiramate

    153 1Torsemide

    154 1Tramadol Hydrochloride

    155 1Trimetazidine Hydrochloride

    156 1Tropicamide

    157 1Voglibose

    158 1Zoledronic Acid

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    01

    Glycopyrronium Bromide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
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    Glycopyrronium Bromide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    RDD
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-06-20

    Pay. Date : 2019-05-03

    DMF Number : 33806

    Submission : 2019-05-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Acamprosate Calcium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    03

    Aceclofenac

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    04

    Alpha/Beta-Arteether

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    05

    Amisulpride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    06

    Amitriptyline Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    07

    Amlodipine Besylate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    08

    Amorolfine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    09

    Anastrozole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow

    10

    Aripiprazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    RDD
    Not Confirmed
    arrow
    Contact Nishchem International Pvt. Ltd and get a quotation

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