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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fleming Laboratories

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    01 Bimatoprost (1)

    02 Buclizine Hydrochloride (1)

    03 Carisoprodol (1)

    04 Cilostazol (1)

    05 Cinnarizine (1)

    06 Cyclizine Hydrochloride (1)

    07 Cyclobenzaprine (1)

    08 Cyproheptadine Hydrochloride (1)

    09 Dapsone (1)

    10 Diltiazem Hydrochloride (1)

    11 Etodolac (1)

    12 Flunarizine (1)

    13 Hydroxyzine Dihydrochloride (1)

    14 Hydroxyzine Pamoate (1)

    15 Ibandronate Sodium (1)

    16 Ketotifen Fumarate (1)

    17 Latanoprost (1)

    18 Latanoprostene Bunod (1)

    19 Loperamide Hydrochloride (1)

    20 Lurasidone Hydrochloride (1)

    21 Meclizine Hydrochloride (1)

    22 Misoprostol (1)

    23 Oxatomide (1)

    24 Penicillamine (2)

    25 Pentoxifylline (1)

    26 Ramelteon (1)

    27 Risedronate Sodium (1)

    28 Tolterodine Tartrate (1)

    29 Topiramate (1)

    30 Trimetazidine (1)

    31 Trospium Chloride (1)

    filter

    01 Active (1)

    02 Inactive (4)

    03 Blank (27)

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    01 Valid (6)

    02 Blank (26)

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    01 Blank (32)

    filter

    01 WC-0229 (2)

    02 WC-0229A2 (6)

    03 WC-0229A3 (4)

    04 WC-0491 (5)

    05 WC-0491A3 (1)

    06 Blank (14)

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    Etodolac

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    USDMF

    Caution USDMF

    31967
    Inactive
    ETODOLAC USP
    2017-11-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-180 - Rev 00
    Valid
    Etodolac
    2023-05-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229
    Expired
    Etodolac USP
    2019-08-13
    Application Number
    31967
    R1-CEP 2015-180 - Rev 00
    Indian CDSCO WC-0229
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    ETODOLAC USP
    Etodolac
    Etodolac USP
    Issue/Submission Date
    2017-11-11
    2023-05-02
    2019-08-13
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    Meclizine Hydrochloride

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    USDMF

    Caution USDMF

    20470
    Inactive
    MECLIZINE HCL USP
    2007-04-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-031 - Rev 00
    Valid
    Meclozine dihydrochloride
    2020-09-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Meclizine / Meclozine Hydrochloride...
    2020-06-18
    Application Number
    20470
    R0-CEP 2017-031 - Rev 00
    Indian CDSCO WC-0229A2
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-13
    Filing Details
    MECLIZINE HCL USP
    Meclozine dihydrochloride
    Meclizine / Meclozine Hydrochloride...
    Issue/Submission Date
    2007-04-23
    2020-09-21
    2020-06-18
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    Cinnarizine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-019 - Rev 00
    Valid
    Cinnarizine
    2022-05-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229
    Expired
    Cinnarazine BP/EP
    2019-08-13
    Application Number
    R1-CEP 2015-019 - Rev 00
    Indian CDSCO WC-0229
    Status
    Valid
     
    Expired
    2022-08-12
    Filing Details
    Cinnarizine
    Cinnarazine BP/EP
    Issue/Submission Date
    2022-05-09
    2019-08-13
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    Diltiazem Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-181 - Rev 00
    Valid
    Diltiazem hydrochloride
    2023-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Diltiazem Hydrochloride EP/USP
    2021-01-22
    Application Number
    R0-CEP 2020-181 - Rev 00
    Indian CDSCO WC-0229A3
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Diltiazem hydrochloride
    Diltiazem Hydrochloride EP/USP
    Issue/Submission Date
    2023-01-11
    2021-01-22
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    Flunarizine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2016-231 - Rev 01
    Valid
    Flunarizine dihydrochloride
    2023-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Flunarizine Dihydrochloride BP/EP
    2020-06-18
    Application Number
    CEP 2016-231 - Rev 01
    Indian CDSCO WC-0229A2
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Flunarizine dihydrochloride
    Flunarizine Dihydrochloride BP/EP
    Issue/Submission Date
    2023-09-27
    2020-06-18
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    Hydroxyzine Dihydrochloride

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    USDMF

    Found USDMF

    38273
    Active
    HYDROXYZINE HYDROCHLORIDE USP
    2023-08-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Hydroxyzine HCl USP
    2021-01-22
    Application Number
    38273
    Indian CDSCO WC-0229A3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-08-13
    Filing Details
    HYDROXYZINE HYDROCHLORIDE USP
    Hydroxyzine HCl USP
    Issue/Submission Date
    2023-08-10
    2021-01-22
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    Loperamide Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2016-168 - Rev 02
    Valid
    Loperamide hydrochloride
    2022-05-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Loperamide Hydrochloride BP/EP/USP
    2020-06-18
    Application Number
    R0-CEP 2016-168 - Rev 02
    Indian CDSCO WC-0229A2
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Loperamide hydrochloride
    Loperamide Hydrochloride BP/EP/USP
    Issue/Submission Date
    2022-05-05
    2020-06-18
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    Carisoprodol

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    USDMF

    Caution USDMF

    31965
    Inactive
    CARISOPRODOL USP
    2017-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Carisoprodol USP/EP
    2020-06-18
    Application Number
    31965
    Indian CDSCO WC-0229A2
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-13
    Filing Details
    CARISOPRODOL USP
    Carisoprodol USP/EP
    Issue/Submission Date
    2017-08-09
    2020-06-18
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    Buclizine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Buclizine Hydrochloride BP
    2020-06-18
    Application Number
    Indian CDSCO WC-0229A2
    Status
     
    Expired
    2022-08-13
    Filing Details
    Buclizine Hydrochloride BP
    Issue/Submission Date
    2020-06-18
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    Cyclizine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Cyclizine Hydrochloride EP
    2021-01-22
    Application Number
    Indian CDSCO WC-0229A3
    Status
     
    Expired
    2022-08-13
    Filing Details
    Cyclizine Hydrochloride EP
    Issue/Submission Date
    2021-01-22
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