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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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    Doxazosin Mesylate

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-257 - Rev 00
    Valid
    Doxazosin mesilate
    2024-04-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Doxazosin Mesilate EP/BP
    2021-06-01
    Application Number
    CEP 2022-257 - Rev 00
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Doxazosin mesilate
    Doxazosin Mesilate EP/BP
    Issue/Submission Date
    2024-04-15
    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

    Close JDMF

    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

    Close JDMF

    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

    Close JDMF

    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

    CEP 2020-166 - Rev 02
    Valid
    Rabeprazole sodium hydrate
    2024-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Rabeprazole Sodium hydrate EP/dexra...
    2021-06-01
    Application Number
    CEP 2020-166 - Rev 02
    Indian CDSCO WC-0316n
    Status
    Valid
     
    Expired
    2024-04-04
    Filing Details
    Rabeprazole sodium hydrate
    Rabeprazole Sodium hydrate EP/dexra...
    Issue/Submission Date
    2024-03-28
    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

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    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

    Close JDMF

    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

    Close CEP/COS

    Japanese DMF

    Close JDMF

    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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    CAS 153259-31-5

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    USDMF

    Caution USDMF

    29155
    Inactive
    2-CHLOROMETHYL-3-METHYL-4-(3-METHOX...
    2015-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29155
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    2-CHLOROMETHYL-3-METHYL-4-(3-METHOX...
    Issue/Submission Date
    2015-03-09
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    Dexlansoprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Dexlansoprazole IH
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Dexlansoprazole IH
    Issue/Submission Date
    2018-04-05
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    Dexlansoprazole

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

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Doxazosin Mesylate (BP / Ph. Eur.)
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Doxazosin Mesylate (BP / Ph. Eur.)
    Issue/Submission Date
    2018-04-05
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    Duloxetine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Duloxetine HCl USP
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Duloxetine HCl USP
    Issue/Submission Date
    2018-04-05
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    Duloxetine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Duloxetine Hydrochloride USP
    2021-06-01
    Application Number
    Indian CDSCO WC-0316n
    Status
     
    Expired
    2024-04-04
    Filing Details
    Duloxetine Hydrochloride USP
    Issue/Submission Date
    2021-06-01
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    Esomeprazole Magnesium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Esomeprazoie Magnesium Trihydrate (...
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Esomeprazoie Magnesium Trihydrate (...
    Issue/Submission Date
    2018-04-05
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    Esomeprazole Magnesium

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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
    Esomeprazole Magnesium USP
    2020-11-05
    Application Number
    Indian CDSCO WC-0316A2
    Status
     
    Expired
    2021-04-04
    Filing Details
    Esomeprazole Magnesium USP
    Issue/Submission Date
    2020-11-05
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    Febuxostat

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    USDMF

    Caution USDMF

    33454
    Inactive
    ETHYL-2-(3-FORMYL-4-HYDROXY PHENYL)...
    2019-01-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33454
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ETHYL-2-(3-FORMYL-4-HYDROXY PHENYL)...
    Issue/Submission Date
    2019-01-11
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    Itraconazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Itraconazole (BP / Ph. Eur.)
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Itraconazole (BP / Ph. Eur.)
    Issue/Submission Date
    2018-04-05
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    Itraconazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Itraconazole EP/BP
    2021-06-01
    Application Number
    Indian CDSCO WC-0316n
    Status
     
    Expired
    2024-04-04
    Filing Details
    Itraconazole EP/BP
    Issue/Submission Date
    2021-06-01
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    Lansoprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Lansoprazole (BP / Ph. Eur.)
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Lansoprazole (BP / Ph. Eur.)
    Issue/Submission Date
    2018-04-05
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    Omeprazole

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

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0316n
    Expired
    Omeprazole USP
    2021-06-01
    Application Number
    Indian CDSCO WC-0316n
    Status
     
    Expired
    2024-04-04
    Filing Details
    Omeprazole USP
    Issue/Submission Date
    2021-06-01
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    Quetiapine Hemifumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Quetiapine Fumarate (IH)
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Quetiapine Fumarate (IH)
    Issue/Submission Date
    2018-04-05
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    Rabeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-316
    Expired
    Rabeprazoie Sodium (IH)
    2018-04-05
    Application Number
    Indian CDSCO WC-316
    Status
     
    Expired
    2021-04-05
    Filing Details
    Rabeprazoie Sodium (IH)
    Issue/Submission Date
    2018-04-05
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    Rabeprazole

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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
    Rabeprazole Sodium hydrate EP/ Dex-...
    2020-11-05
    Application Number
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    DIBENZO [B,F] [1,4] THIAZEPIN-11 (1...
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