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    01 Afatinib (1)

    02 Alectinib Hydrochloride (1)

    03 Amoxicillin Sodium (1)

    04 Ampicillin Sodium (4)

    05 Ampicillin Trihydrate (1)

    06 Anastrozole (2)

    07 Bacampicillin (2)

    08 Belinostat (1)

    09 Bendamustine Hydrochloride (2)

    10 Benzylpenicillin Sodium (2)

    11 Bicalutamide (2)

    12 Bortezomib (1)

    13 Buflomedil (1)

    14 Bupivacaine Hydrochloride (1)

    15 Busulfan (2)

    16 Cabazitaxel (1)

    17 Calcitonin (1)

    18 Carboplatin (2)

    19 Carfilzomib (1)

    20 Cefalotin sodium Sterile (1)

    21 Cefatrizine (1)

    22 Cefazolin Sodium (2)

    23 Cefepime (1)

    24 Cefepime Hydrochloride (1)

    25 Cefoperazone Sodium (1)

    26 Cefotaxime (1)

    27 Cefoxitin Sodium (2)

    28 Ceftazidime (3)

    29 Ceftriaxone (4)

    30 Cefuroxime Sodium (2)

    31 Cephapirin Benzathine (1)

    32 Cephapirin Sodium (1)

    33 Cisplatin (1)

    34 Cloxacillin Benzathine (1)

    35 Cloxacillin Sodium (2)

    36 Cornstarch (2)

    37 Decitabine (2)

    38 Degarelix Acetate (1)

    39 Disodium Pamidronate Pentahydrate (1)

    40 Docetaxel (4)

    41 Erlotinib Hydrochloride (1)

    42 Flucloxacillin Sodium (2)

    43 Gefitinib (1)

    44 Gemcitabine (5)

    45 Glucagon (1)

    46 Hetacillin Potassium (1)

    47 Ibrutinib (1)

    48 Imatinib Mesylate (1)

    49 Irinotecan Hydrochloride (3)

    50 L-Arginine Hydrochloride API (1)

    51 Lactulose (7)

    52 Letrozole (2)

    53 Levobupivacaine (1)

    54 Liraglutide (1)

    55 Metaxalone (1)

    56 Nafcillin Sodium (1)

    57 Octreotide Acetate (1)

    58 Oxacillin Sodium (1)

    59 Oxaliplatin (2)

    60 Paclitaxel (2)

    61 Pemetrexed Disodium (1)

    62 Penicillin G Potassium (1)

    63 Piperacillin + Tazobactam (1)

    64 Piperacillin Sodium (2)

    65 Pivmecillinam (2)

    66 Plerixafor (1)

    67 Ribociclib (1)

    68 Ropivacaine Hydrochloride (3)

    69 Sodium Dicloxacillin (2)

    70 Sugammadex Sodium (1)

    71 Sulbactam Sodium (1)

    72 Tazobactam Sodium (1)

    73 Temsirolimus (1)

    74 Topotecan Hydrochloride (1)

    75 Blank (5)

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    02 Valid (40)

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    01 221MF10291 (1)

    02 224MF10032 (1)

    03 224MF10181 (1)

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    01 WC-0115 (19)

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    Afatinib

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    USDMF

    Found USDMF

    30927
    Active
    AFATINIB DIMALEATE
    2016-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Afatinib Dimaleate IH
    2022-09-30
    Application Number
    30927
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    AFATINIB DIMALEATE
    Afatinib Dimaleate IH
    Issue/Submission Date
    2016-12-31
    2022-09-30
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    Alectinib Hydrochloride

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    USDMF

    Found USDMF

    33869
    Active
    ALECTINIB HYDROCHLORIDE
    2019-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Alectinib Hydrochloride IH
    2022-09-30
    Application Number
    33869
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    ALECTINIB HYDROCHLORIDE
    Alectinib Hydrochloride IH
    Issue/Submission Date
    2019-06-12
    2022-09-30
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    Amoxicillin Sodium

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    USDMF

    Found USDMF

    38349
    Active
    AMOXICILLIN SODIUM STERILE
    2023-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-267 - Rev 07
    Valid
    Amoxicillin sodium
    2022-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38349
    R1-CEP 2008-267 - Rev 07
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN SODIUM STERILE
    Amoxicillin sodium
    Issue/Submission Date
    2023-05-17
    2022-10-11
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    Carfilzomib

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    USDMF

    Found USDMF

    29750
    Active
    CARFILZOMIB
    2016-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Carfilzomib IH
    2022-09-30
    Application Number
    29750
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    CARFILZOMIB
    Carfilzomib IH
    Issue/Submission Date
    2016-01-30
    2022-09-30
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      Cefepime Hydrochloride

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      USDMF

      Found USDMF

      27971
      Active
      CEFEPIME HYDROCHLORIDE STERILE
      2014-01-20
      CEP/COS

      Found CEP/COS

      CEP 2022-460 - Rev 00
      Valid
      Cefepime dihydrochloride monohydrat...
      2023-09-13
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      27971
      CEP 2022-460 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      CEFEPIME HYDROCHLORIDE STERILE
      Cefepime dihydrochloride monohydrat...
      Issue/Submission Date
      2014-01-20
      2023-09-13
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      Cloxacillin Sodium

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      USDMF

      Found USDMF

      38038
      Active
      CLOXACILLIN SODIUM
      2023-04-18
      CEP/COS

      Found CEP/COS

      R1-CEP 1998-025 - Rev 08
      Valid
      Cloxacillin sodium, Sterile
      2021-06-10
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      38038
      R1-CEP 1998-025 - Rev 08
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      CLOXACILLIN SODIUM
      Cloxacillin sodium, Sterile
      Issue/Submission Date
      2023-04-18
      2021-06-10
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      Ibrutinib

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      USDMF

      Found USDMF

      31199
      Active
      IBRUTINIB
      2017-05-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Found WC

      Indian CDSCO WC-0115A3
      Valid
      Ibrutinib IH
      2022-09-30
      Application Number
      31199
      Indian CDSCO WC-0115A3
      Status
      Active
      Fees Paid
      N/A
       
      Valid
      2025-09-15
      Filing Details
      IBRUTINIB
      Ibrutinib IH
      Issue/Submission Date
      2017-05-12
      2022-09-30
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        Lactulose

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        USDMF

        Found USDMF

        15253
        Active
        LACTULOSE SOLUTION USP
        2001-02-16
        CEP/COS

        Found CEP/COS

        R1-CEP 2005-023 - Rev 02
        Valid
        Lactulose, liquid
        2017-09-07
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        15253
        R1-CEP 2005-023 - Rev 02
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Filing Details
        LACTULOSE SOLUTION USP
        Lactulose, liquid
        Issue/Submission Date
        2001-02-16
        2017-09-07
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          Lactulose

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          USDMF

          Found USDMF

          15254
          Active
          LACTULOSE CRYSTALS
          2001-02-16
          CEP/COS

          Found CEP/COS

          R1-CEP 2002-236 - Rev 03
          Valid
          Lactulose
          2017-10-11
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          15254
          R1-CEP 2002-236 - Rev 03
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          LACTULOSE CRYSTALS
          Lactulose
          Issue/Submission Date
          2001-02-16
          2017-10-11
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            Lactulose

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            USDMF

            Found USDMF

            20562
            Active
            LACTULOSE CONCENTRATE USP
            2007-05-29
            CEP/COS

            Found CEP/COS

            R0-CEP 2019-138 - Rev 00
            Valid
            Lactulose, liquid, 667 g/L
            2019-11-15
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            20562
            R0-CEP 2019-138 - Rev 00
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Filing Details
            LACTULOSE CONCENTRATE USP
            Lactulose, liquid, 667 g/L
            Issue/Submission Date
            2007-05-29
            2019-11-15
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