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    01 Agomelatine (1)

    02 Anagrelide Hydrochloride (1)

    03 Apixaban (1)

    04 Aprepitant (1)

    05 Azithromycin (1)

    06 Azithromycin Dihydrate (1)

    07 Bazedoxifene Acetate (1)

    08 Bisoprolol Fumarate (1)

    09 Chloramphenicol Palmitate (1)

    10 Chloramphenicol Succinate Acid (1)

    11 Cinacalcet Hydrochloride (1)

    12 Dabigatran Etexilate Mesylate (1)

    13 Dapagliflozin Propanediol Monohydrate (1)

    14 Dipyridamole (1)

    15 Droperidol (1)

    16 Edoxaban Tosylate (1)

    17 Empagliflozin (1)

    18 Erythromycin (1)

    19 Erythromycin Estolate (1)

    20 Erythromycin Ethyl Succinate (1)

    21 Erythromycin Stearate (1)

    22 Esmolol Hydrochloride (1)

    23 Fluvoxamine (1)

    24 Landiolol Hydrochloride (1)

    25 Linagliptin (1)

    26 Luliconazole (1)

    27 Mirabegron (1)

    28 Pazopanib Hydrochloride (1)

    29 Pirfenidone (1)

    30 Pomalidomide (1)

    31 Prochlorperazine Maleate (1)

    32 Prochlorperazine Mesylate (1)

    33 Rivaroxaban (1)

    34 Sapropterin Hydrochloride (1)

    35 Sorafenib (1)

    36 Tamsulosin (1)

    37 Teriflunomide (1)

    38 Tofacitinib Citrate (1)

    39 Treprostinil Sodium (1)

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    01 Active (1)

    02 Blank (38)

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    01 Valid (1)

    02 Withdrawn by EDQM Failure to CEP procedure (2)

    03 Blank (36)

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    01 304MF10161 (1)

    02 Blank (38)

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    01 WC-0214 (20)

    02 Blank (19)

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    Aprepitant

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    304MF10161
    Appropriate USP at 811, Summit Busi...
    2022-12-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Aprepitant IH/USP/EP at Gut No. 546...
    2020-02-14
    Application Number
    304MF10161
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Appropriate USP at 811, Summit Busi...
    Aprepitant IH/USP/EP at Gut No. 546...
    Issue/Submission Date
    2022-12-23
    2020-02-14
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    Esmolol Hydrochloride

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    USDMF

    Found USDMF

    39475
    Active
    ESMOLOL HCL USP
    2024-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Esmolol Hydrochloride IH/USP at Gut...
    2020-02-14
    Application Number
    39475
    Indian CDSCO WC-0214
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    ESMOLOL HCL USP
    Esmolol Hydrochloride IH/USP at Gut...
    Issue/Submission Date
    2024-01-31
    2020-02-14
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    Rivaroxaban

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-212 - Rev 00
    Valid
    Rivaroxaban
    2024-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Rivaroxaban IH at Gut No. 546, 571,...
    2020-02-14
    Application Number
    CEP 2022-212 - Rev 00
    Indian CDSCO WC-0214
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Rivaroxaban
    Rivaroxaban IH at Gut No. 546, 571,...
    Issue/Submission Date
    2024-05-30
    2020-02-14
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    Bisoprolol Fumarate

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-342 - Rev 02
    Withdrawn by EDQM Failure to CEP procedure
    Bisoprolol fumarate
    2019-05-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Bisoprolol Fumarate USP/EP at Gut N...
    2020-02-14
    Application Number
    R0-CEP 2013-342 - Rev 02
    Indian CDSCO WC-0214
    Status
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2022-07-02
    Filing Details
    Bisoprolol fumarate
    Bisoprolol Fumarate USP/EP at Gut N...
    Issue/Submission Date
    2019-05-13
    2020-02-14
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    Erythromycin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2009-267 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Erythromycin
    2019-06-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Erythromycin BP/EPUSP at Gut No. 54...
    2020-02-14
    Application Number
    R1-CEP 2009-267 - Rev 01
    Indian CDSCO WC-0214
    Status
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2022-07-02
    Filing Details
    Erythromycin
    Erythromycin BP/EPUSP at Gut No. 54...
    Issue/Submission Date
    2019-06-11
    2020-02-14
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    Agomelatine

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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-0214
    Expired
    Agomelatine IH at Gut No. 546, 571,...
    2020-02-14
    Application Number
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Agomelatine IH at Gut No. 546, 571,...
    Issue/Submission Date
    2020-02-14
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    Anagrelide Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Anagrelide Hydrocholoride IH at Gut...
    2020-02-14
    Application Number
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Anagrelide Hydrocholoride IH at Gut...
    Issue/Submission Date
    2020-02-14
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Azithromycin BP/EP/USP at Gut No. 5...
    2020-02-14
    Application Number
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Azithromycin BP/EP/USP at Gut No. 5...
    Issue/Submission Date
    2020-02-14
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    Chloramphenicol Palmitate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Chloramphenicol Palmitate BP/EP/USP...
    2020-02-14
    Application Number
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Chloramphenicol Palmitate BP/EP/USP...
    Issue/Submission Date
    2020-02-14
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    Chloramphenicol Succinate Acid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0214
    Expired
    Chloramphenicol BP/EP/USP at Gut No...
    2020-02-14
    Application Number
    Indian CDSCO WC-0214
    Status
     
    Expired
    2022-07-02
    Filing Details
    Chloramphenicol BP/EP/USP at Gut No...
    Issue/Submission Date
    2020-02-14
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