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    01 Apixaban (2)

    02 Aripiprazole (2)

    03 Azilsartan (1)

    04 Benzimidazole (1)

    05 Betrixaban Maleate (1)

    06 Brexpiprazole (1)

    07 CAS 153259-31-5 (1)

    08 Cariprazine Hydrochloride (1)

    09 Cilostazol (1)

    10 Dabigatran Etexilate Mesylate (1)

    11 Daclatasvir (1)

    12 Deferasirox (1)

    13 Dexlansoprazole (2)

    14 Diltiazem Hydrochloride (1)

    15 Doxazosin Mesylate (2)

    16 Duloxetine (2)

    17 Edoxaban Tosylate (1)

    18 Efinaconazole (1)

    19 Esomeprazole Magnesium (3)

    20 Etodolac (1)

    21 Febuxostat (1)

    22 Ilaprazole (1)

    23 Itraconazole (2)

    24 Ivabradine Hydrochloride (1)

    25 Lansoprazole (2)

    26 Lesinurad (1)

    27 Mirtazapine (1)

    28 Olanzapine (1)

    29 Omeprazole (2)

    30 Paliperidone (1)

    31 Quetiapine Hemifumarate (2)

    32 Rabeprazole (3)

    33 Racecadotril (1)

    34 Ranolazine (1)

    35 Ravidasvir (1)

    36 Revaprazan (1)

    37 Rivaroxaban (2)

    38 Safinamide Mesylate (1)

    39 Sibutramine Hydrochloride (1)

    40 Sitagliptin Phosphate (1)

    41 Tenatoprazole sodium (1)

    42 Tianeptine (1)

    43 Ticagrelor (1)

    44 Topiramate (2)

    45 Topiroxostat (1)

    46 Trazodone Hydrochloride (1)

    47 Vilazodone (1)

    48 Vildagliptin (1)

    49 Vonoprazan Fumarate (1)

    50 Blank (1)

    filter

    01 Inactive (4)

    02 Blank (61)

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    01 Valid (6)

    02 Blank (59)

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    01 Blank (65)

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    01 WC-0316A2 (5)

    02 WC-0316n (13)

    03 WC-316 (10)

    04 Blank (37)

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    Aripiprazole

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2017-198 - Rev 02
    Valid
    Aripiprazole
    2022-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Aripiprazole EP/BP
    2021-06-01
    Application Number
    R0-CEP 2017-198 - Rev 02
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Aripiprazole
    Aripiprazole EP/BP
    Issue/Submission Date
    2022-08-16
    2021-06-01
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    Esomeprazole Magnesium

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2018-245 - Rev 02
    Valid
    Esomeprazole magnesium trihydrate
    2023-12-12
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Esomeprazole Magnesium Trihydrate ...
    2021-06-01
    Application Number
    CEP 2018-245 - Rev 02
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Esomeprazole magnesium trihydrate
    Esomeprazole Magnesium Trihydrate ...
    Issue/Submission Date
    2023-12-12
    2021-06-01
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    Lansoprazole

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2010-297 - Rev 03
    Valid
    Lansoprazole
    2024-03-26
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Lansoprazole EP/BP
    2021-06-01
    Application Number
    CEP 2010-297 - Rev 03
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Lansoprazole
    Lansoprazole EP/BP
    Issue/Submission Date
    2024-03-26
    2021-06-01
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    Quetiapine Hemifumarate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2021-289 - Rev 02
    Valid
    Quetiapine Fumarate, Process II
    2023-06-15
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Quetiapine Fumarate IH
    2021-06-01
    Application Number
    R0-CEP 2021-289 - Rev 02
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Quetiapine Fumarate, Process II
    Quetiapine Fumarate IH
    Issue/Submission Date
    2023-06-15
    2021-06-01
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    Rabeprazole

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2020-166 - Rev 01
    Valid
    Rabeprazole sodium hydrate
    2022-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Rabeprazole Sodium hydrate EP/dexra...
    2021-06-01
    Application Number
    R0-CEP 2020-166 - Rev 01
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Rabeprazole sodium hydrate
    Rabeprazole Sodium hydrate EP/dexra...
    Issue/Submission Date
    2022-08-16
    2021-06-01
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    Quetiapine Fumarate, Process-I

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2021-187 - Rev 00
    Valid
    Quetiapine Fumarate, Process-I
    2024-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-187 - Rev 00
    Status
    Valid
     
    Filing Details
    Quetiapine Fumarate, Process-I
    Issue/Submission Date
    2024-02-28
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    Apixaban

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316A2
    Expired
    Apixaban IH
    2020-11-05
    Application Number
    Indian CDSCO WC-0316A2
    Status
     
    Expired
    2021-04-04
    Filing Details
    Apixaban IH
    Issue/Submission Date
    2020-11-05
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    Apixaban

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Apixaban IH
    2021-06-01
    Application Number
    Indian CDSCO WC-0316n
    Status
     
    Expired
    2024-04-04
    Filing Details
    Apixaban IH
    Issue/Submission Date
    2021-06-01
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    Aripiprazole

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Aripiprazole BP/EP
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Aripiprazole BP/EP
    Issue/Submission Date
    2018-04-05
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    Benzimidazole

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    USDMF

    Caution USDMF

    29045
    Inactive
    2-[[[3-METHYL-4-(2,2,2-TRIFLUORO ET...
    2015-01-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    29045
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    2-[[[3-METHYL-4-(2,2,2-TRIFLUORO ET...
    Issue/Submission Date
    2015-01-21
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