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    01 1Abrocitinib

    02 1Alcaftadine

    03 1Arginine Vasopressin

    04 1Aripiprazole

    05 1Ataluren

    06 1Avacopan

    07 1Avatrombopag Maleate

    08 1Azacitidine

    09 1Azathioprine

    10 1Bedaquiline

    11 1Belzutifan

    12 1Berotralstat Hydrochloride

    13 1Bexarotene

    14 2Bortezomib

    15 1Brinzolamide

    16 1Brivaracetam

    17 1Bromfenac Sodium

    18 1Busulfan

    19 1Cabergoline

    20 1Cabotegravir

    21 1Carfilzomib

    22 1Cetrorelix Acetate

    23 1Cevimeline Hydrochloride

    24 1Cinitapride Hydrogen Tartrate

    25 1Clofarabine

    26 1Colestipol

    27 1Crizotinib

    28 1Cyclophosphamide

    29 1Cysteamine Bitartrate

    30 1Cysteamine Hydrochloride

    31 1Dacarbazine

    32 3Degarelix Acetate

    33 1Deucravacitinib

    34 1Diflunisal

    35 1Dimetindene

    36 1Dofetilide

    37 1Dolutegravir Sodium

    38 1Droxidopa

    39 1Elacestrant

    40 1Enasidenib

    41 1Ethacrynic Acid

    42 1Favipiravir

    43 1Felbamate

    44 2Ferric Carboxymaltose

    45 1Ferric Citrate

    46 1Ferric Derisomaltose

    47 1Ferric Maltol

    48 1Ferric Pyrophosphate Citrate

    49 1Ferumoxides

    50 1Ferumoxytol

    51 1Flibanserin

    52 1Fludrocortisone Acetate

    53 1Fluocytosine

    54 1Fluorescein

    55 1Fomepizole

    56 1Fondaparinux Sodium

    57 1Fosamprenavir

    58 1Ganirelix

    59 1Granisetron Hydrochloride

    60 1Histrelin

    61 1Hydroxocobalamin

    62 1Hydroxocobalamin Hydrochloride

    63 1Indocyanine Green

    64 1Iron Dextran

    65 1Iron Sucrose

    66 1Isavuconazonium Sulfate

    67 1Isosulfan Blue

    68 1Itraconazole

    69 1Ivacaftor

    70 1Lanreotide Acetate

    71 1Larotrectinib

    72 1Lenacapavir

    73 1Lenalidomide

    74 1Leuprolide Acetate

    75 1Linaclotide

    76 1Liraglutide

    77 1Lumacaftor

    78 1Lurbinectedin

    79 1Mafenide

    80 1Maralixibat

    81 1Mavacamten

    82 1Methylene Blue

    83 1Methyltyrosine

    84 1Micafungin

    85 1Midostaurin

    86 1Miglustat

    87 1Mitapivat

    88 1Mobocertinib Succinate

    89 2Molindone

    90 1Molnupiravir

    91 1Momelotinib

    92 1Nadolol

    93 1Netupitant

    94 1Octreotide Acetate

    95 1Odevixibat

    96 1Oseltamivir Phosphate

    97 1Paliperidone Palmitate

    98 1Pantoprazole Sodium

    99 1Penicillamine

    100 2Pentosan Polysulfate Sodium

    101 1Pentostatin

    102 1Perphenazine

    103 1Phenoxybenzamine HCl

    104 1Phentolamine Mesylate

    105 1Plerixafor

    106 1Pomalidomide

    107 2Ponatinib

    108 1Pralatrexate

    109 2Primaquine Diphosphate

    110 1Procarbazine Hydrochloride

    111 1Protriptyline

    112 1Prucalopride Succinate

    113 1Raltegravir Potassium

    114 1Regadenoson Monohydrate

    115 1Rilpivirine Hydrochloride

    116 1Riluzole

    117 1Ritlecitinib

    118 1Romidepsin

    119 1Rucaparib Camsylate

    120 1Safinamide Methanesulfonate

    121 1Selegiline Hydrochloride

    122 1Selenious Acid

    123 1Selexipag

    124 1Semaglutide

    125 1Sincalide

    126 1Sodium Nitroprusside

    127 1Sodium Zirconium Cyclosilicate

    128 1Sparsentan

    129 2Sugammadex Sodium

    130 1Sulfiram

    131 1Tecovirimat

    132 1Teduglutide

    133 1Tenofovir Alafenamide Fumarate

    134 1Tetrabenazine

    135 1Tirzepatide

    136 2Trabectedin

    137 1Triamterene

    138 1Trientine Hydrochloride

    139 1Trifluridine

    140 1Trilaciclib

    141 1Triptorelin Pamoate

    142 1Umifenovir

    143 1Ursodeoxycholic Acid

    144 1VANDETANIB

    145 1Vismodegib

    146 1Voriconazole

    147 1Vortioxetine Hydrobromide

    148 1Vosoritide

    149 1Zavegepant HCl

    150 1Zileuton

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    01

    Bortezomib

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

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    Bortezomib

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-20

    DMF Number : 22922

    Submission : 2009-06-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 231MF10057

    Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

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    NDC Package Code : 42973-140

    Start Marketing Date : 2009-11-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    02

    Busulfan

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

    ChemOutsourcing
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    Busulfan

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-05-27

    DMF Number : 23924

    Submission : 2010-08-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2016-270 - Rev 00

    Issue Date : 2023-05-17

    Type : Chemical

    Substance Number : 542

    Status : Valid

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    NDC Package Code : 14096-147

    Start Marketing Date : 2011-07-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

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    03

    Phentolamine Mesylate

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

    ChemOutsourcing
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    Phentolamine Mesylate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39948

    Submission : 2024-06-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

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    04

    Trabectedin

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

    ChemOutsourcing
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    Trabectedin

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-07-13

    Pay. Date : 2021-06-07

    DMF Number : 35828

    Submission : 2021-04-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

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    NDC Package Code : 42973-310

    Start Marketing Date : 2020-12-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

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    05

    Alcaftadine

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

    ChemOutsourcing
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    Alcaftadine

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32382

    Submission : 2018-01-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 42973-204

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Bexarotene

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

    ChemOutsourcing
    Not Confirmed
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    Bexarotene

    India

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

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    ChemOutsourcing
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-07

    Pay. Date : 2015-07-29

    DMF Number : 23631

    Submission : 2010-04-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 14096-150

    Start Marketing Date : 2009-10-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Cyclophosphamide

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

    ChemOutsourcing
    Not Confirmed
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    Cyclophosphamide

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-11-15

    Pay. Date : 2021-09-27

    DMF Number : 36089

    Submission : 2021-07-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-318

    Start Marketing Date : 2020-12-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Degarelix Acetate

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

    ChemOutsourcing
    Not Confirmed
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    Degarelix Acetate

    India

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

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    ChemOutsourcing
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37005

    Submission : 2023-04-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-343

    Start Marketing Date : 2022-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    Degarelix Acetate

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

    ChemOutsourcing
    Not Confirmed
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    Degarelix Acetate

    India

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

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    ChemOutsourcing
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37113

    Submission : 2023-04-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-344

    Start Marketing Date : 2022-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Degarelix Acetate

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

    ChemOutsourcing
    Not Confirmed
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    Degarelix Acetate

    India

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

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40970

    Submission : 2024-12-28

    Status : Active

    Type : II

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