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    01 Abacavir (1)

    02 Abacavir Sulfate (3)

    03 Abiraterone Acetate (2)

    04 Adenine (1)

    05 Alectinib Hydrochloride (1)

    06 Atazanavir Sulfate (4)

    07 Atovaquone (1)

    08 Bictegravir (2)

    09 Bortezomib (1)

    10 Cabotegravir Sodium (1)

    11 Canagliflozin (1)

    12 Capecitabine (2)

    13 Carboplatin (1)

    14 Dabigatran Etexilate Mesylate (2)

    15 Daclatasvir (1)

    16 Dasatinib (3)

    17 Dolutegravir Sodium (1)

    18 Edoxaban Tosylate (1)

    19 Efavirenz (2)

    20 Elagolix Sodium (2)

    21 Eltrombopag (1)

    22 Elvitegravir (1)

    23 Emtricitabine (1)

    24 Enzalutamide (2)

    25 Erlotinib (2)

    26 Erlotinib Hydrochloride (2)

    27 Gefitinib (2)

    28 Ibrutinib (2)

    29 Imatinib Mesylate (4)

    30 Irinotecan Hydrochloride (1)

    31 Isavuconazonium Sulfate (1)

    32 Lamivudine (3)

    33 Lopinavir (3)

    34 Lumefantrine (1)

    35 Mefloquine (1)

    36 Nevirapine (2)

    37 Nilotinib (2)

    38 Nintedanib Esylate (1)

    39 Olaparib (1)

    40 Oseltamivir Phosphate (3)

    41 Palbociclib (2)

    42 Pazopanib Hydrochloride (2)

    43 Pemetrexed Disodium (2)

    44 Praziquantel (2)

    45 Ribociclib (1)

    46 Rilpivirine Hydrochloride (1)

    47 Ritonavir (3)

    48 Rosuvastatin Calcium (1)

    49 Ruxolitinib Phosphate (1)

    50 Sorafenib (2)

    51 Stavudine (1)

    52 Sunitinib (2)

    53 Tenofovir (1)

    54 Tenofovir Alafenamide Fumarate (3)

    55 Tenofovir Disoproxil Fumarate (3)

    56 Thiamine Hydrochloride (1)

    57 Vitamin B1 (1)

    58 Zidovudine (2)

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    01 Active (42)

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    03 Blank (54)

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    01 Valid (12)

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    01 221MF10088 (1)

    02 222MF10041 (1)

    03 231MF10064 (1)

    04 305MF10101 (1)

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    01 WC-0327 (2)

    02 WC-0327n (7)

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      Sunitinib

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      USDMF

      Found USDMF

      36392
      Active
      SUNITINIB MALATE
      2021-10-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      305MF10101
      Sunitinib Malate at No. 77D & 116/1...
      2023-08-30
      Written Confirmation

      Found WC

      Indian CDSCO WC-0327n
      Valid
      Sunitinib Malate
      2021-09-01
      Application Number
      36392
      305MF10101
      Indian CDSCO WC-0327n
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Valid
      2024-07-15
      Filing Details
      SUNITINIB MALATE
      Sunitinib Malate at No. 77D & 116/1...
      Sunitinib Malate
      Issue/Submission Date
      2021-10-12
      2023-08-30
      2021-09-01
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      Capecitabine

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      USDMF

      Found USDMF

      25054
      Active
      CAPECITABINE USP [DRUG SUBSTANCE (N...
      2011-06-14
      CEP/COS

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      Japanese DMF

      Found JDMF

      231MF10064
      Capecitabine at No. 77D & 116/117, ...
      2019-03-05
      Written Confirmation

      Close WC

      Application Number
      25054
      231MF10064
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      CAPECITABINE USP [DRUG SUBSTANCE (N...
      Capecitabine at No. 77D & 116/117, ...
      Issue/Submission Date
      2011-06-14
      2019-03-05
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        Capecitabine

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        USDMF

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        CEP/COS

        Found CEP/COS

        R1-CEP 2013-309 - Rev 03
        Valid
        Capecitabine
        2021-09-08
        Japanese DMF

        Close JDMF

        Written Confirmation

        Found WC

        Indian CDSCO WC-0327n
        Valid
        Capecitabin USP/EP/IP/IH
        2021-09-01
        Application Number
        R1-CEP 2013-309 - Rev 03
        Indian CDSCO WC-0327n
        Status
        Valid
         
        Valid
        2024-07-15
        Filing Details
        Capecitabine
        Capecitabin USP/EP/IP/IH
        Issue/Submission Date
        2021-09-08
        2021-09-01
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          Dasatinib

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          USDMF

          Found USDMF

          35990
          Active
          DASATINIB [DRUG SUBSTANCE (NON-STER...
          2021-06-02
          CEP/COS

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          Japanese DMF

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          Written Confirmation

          Found WC

          Indian CDSCO WC-0327n
          Valid
          Dasatinib IH
          2021-09-01
          Application Number
          35990
          Indian CDSCO WC-0327n
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Valid
          2024-07-15
          Filing Details
          DASATINIB [DRUG SUBSTANCE (NON-STER...
          Dasatinib IH
          Issue/Submission Date
          2021-06-02
          2021-09-01
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            Erlotinib Hydrochloride

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            USDMF

            Found USDMF

            36007
            Active
            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            2021-06-04
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Found WC

            Indian CDSCO WC-0327n
            Valid
            Erlotinib Hydrochloride IH
            2021-09-01
            Application Number
            36007
            Indian CDSCO WC-0327n
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Valid
            2024-07-15
            Filing Details
            ERLOTINIB HYDROCHLORIDE [DRUG SUBST...
            Erlotinib Hydrochloride IH
            Issue/Submission Date
            2021-06-04
            2021-09-01
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              Imatinib Mesylate

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              USDMF

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              CEP/COS

              Found CEP/COS

              CEP 2023-221 - Rev 00
              Valid
              Imatinib mesilate, Process 2
              2023-10-30
              Japanese DMF

              Close JDMF

              Written Confirmation

              Found WC

              Indian CDSCO WC-0327n
              Valid
              Imatinib Mesilate IH
              2021-09-01
              Application Number
              CEP 2023-221 - Rev 00
              Indian CDSCO WC-0327n
              Status
              Valid
               
              Valid
              2024-07-15
              Filing Details
              Imatinib mesilate, Process 2
              Imatinib Mesilate IH
              Issue/Submission Date
              2023-10-30
              2021-09-01
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                Pazopanib Hydrochloride

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                USDMF

                Found USDMF

                33054
                Active
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                2018-07-28
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Found WC

                Indian CDSCO WC-0327n
                Valid
                Pazopanib HCl IH
                2021-09-01
                Application Number
                33054
                Indian CDSCO WC-0327n
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Valid
                2024-07-15
                Filing Details
                PAZOPANIB HCL (NON-STERILE DRUG SUB...
                Pazopanib HCl IH
                Issue/Submission Date
                2018-07-28
                2021-09-01
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                Erlotinib Hydrochloride

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                USDMF

                Found USDMF

                33226
                Active
                ERLOTINIB HYDROCHLORIDE (NON-STERIL...
                2018-09-29
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Caution WC

                Indian CDSCO WC-0327
                Expired
                Erlotinib Hydrochloride IH
                2019-01-14
                Application Number
                33226
                Indian CDSCO WC-0327
                Status
                Active
                Fees Paid
                N/A
                 
                Expired
                2021-07-15
                Filing Details
                ERLOTINIB HYDROCHLORIDE (NON-STERIL...
                Erlotinib Hydrochloride IH
                Issue/Submission Date
                2018-09-29
                2019-01-14
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                  Abacavir

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                  USDMF

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                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Found WC

                  Indian CDSCO WC-0327n
                  Valid
                  Abacavir IH
                  2021-09-01
                  Application Number
                  Indian CDSCO WC-0327n
                  Status
                   
                  Valid
                  2024-07-15
                  Filing Details
                  Abacavir IH
                  Issue/Submission Date
                  2021-09-01
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                  Abacavir Sulfate

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                  USDMF

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                  CEP/COS

                  Found CEP/COS

                  CEP 2021-179 - Rev 00
                  Valid
                  Abacavir sulfate
                  2023-12-06
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  CEP 2021-179 - Rev 00
                  Status
                  Valid
                   
                  Filing Details
                  Abacavir sulfate
                  Issue/Submission Date
                  2023-12-06
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