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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Urquima S.a. Grupo Uriach

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    Urquima S.A. Grupo Uriach

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    01 Albaconazole (1)

    02 Azelastine Hydrochloride (1)

    03 Carvedilol (1)

    04 Flutrimazole (1)

    05 Glimepiride (1)

    06 Glipizide (1)

    07 Ivabradine Hydrochloride (1)

    08 Oleic Acid Chloride (1)

    09 Olopatadine Hydrochloride (1)

    10 Ropinirole Hydrochloride (1)

    11 Rupatadine Fumarate (1)

    12 Sodium Butyrate (1)

    13 Triflusal (1)

    14 Blank (1)

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    01 Active (5)

    02 Inactive (6)

    03 Blank (3)

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    01 Expired (1)

    02 Valid (7)

    03 Withdrawn by Holder (2)

    04 Blank (4)

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    01 227MF10077 (1)

    02 228MF10183 (1)

    03 Blank (12)

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    01 Blank (14)

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    Rupatadine Fumarate

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    USDMF

    Found USDMF

    36047
    Active
    RUPATADINE FUMARATE
    2021-08-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-202 - Rev 00
    Valid
    Rupatadine fumarate
    2023-08-09
    Japanese DMF

    Found JDMF

    228MF10183
    Rupatajinfumaru salt at Poli(´)gon...
    2016-09-09
    Written Confirmation

    Close WC

    Application Number
    36047
    R1-CEP 2017-202 - Rev 00
    228MF10183
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RUPATADINE FUMARATE
    Rupatadine fumarate
    Rupatajinfumaru salt at Poli(´)gon...
    Issue/Submission Date
    2021-08-09
    2023-08-09
    2016-09-09
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    Ropinirole Hydrochloride

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    USDMF

    Caution USDMF

    17880
    Inactive
    ROPINIROLE HYDROCHLORIDE
    2004-12-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-117 - Rev 00
    Valid
    Ropinirole hydrochloride
    2022-06-10
    Japanese DMF

    Found JDMF

    227MF10077
    Ropinirole hydrochloride at Poli(')...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    17880
    R1-CEP 2016-117 - Rev 00
    227MF10077
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ROPINIROLE HYDROCHLORIDE
    Ropinirole hydrochloride
    Ropinirole hydrochloride at Poli(')...
    Issue/Submission Date
    2004-12-08
    2022-06-10
    2015-03-12
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    20314
    Active
    AZELASTINE HCL
    2007-02-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-097 - Rev 02
    Valid
    Azelastine hydrochloride
    2021-06-16
    Japanese DMF

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    Written Confirmation

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    Application Number
    20314
    R1-CEP 2007-097 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZELASTINE HCL
    Azelastine hydrochloride
    Issue/Submission Date
    2007-02-12
    2021-06-16
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    Glipizide

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    USDMF

    Found USDMF

    10046
    Active
    GLIPIZIDE
    1993-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-114 - Rev 04
    Valid
    Glipizide, Regular - Micronised
    2011-07-08
    Japanese DMF

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    Application Number
    10046
    R1-CEP 1997-114 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GLIPIZIDE
    Glipizide, Regular - Micronised
    Issue/Submission Date
    1993-01-19
    2011-07-08
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    Flutrimazole

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    USDMF

    Caution USDMF

    12806
    Inactive
    FLUTRIMAZOLE
    1997-12-24
    CEP/COS

    Found CEP/COS

    CEP 1999-108 - Rev 04
    Valid
    Flutrimazole
    2023-11-20
    Japanese DMF

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    Written Confirmation

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    Application Number
    12806
    CEP 1999-108 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUTRIMAZOLE
    Flutrimazole
    Issue/Submission Date
    1997-12-24
    2023-11-20
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    Glimepiride

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    USDMF

    Caution USDMF

    18396
    Inactive
    GLIMEPIRIDE, MICRONISED
    2005-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-017 - Rev 03
    Valid
    Glimepiride
    2022-06-10
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    18396
    R1-CEP 2007-017 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GLIMEPIRIDE, MICRONISED
    Glimepiride
    Issue/Submission Date
    2005-06-03
    2022-06-10
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    Carvedilol

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    USDMF

    Caution USDMF

    18158
    Inactive
    CARVEDILOL, MICRONIZED
    2005-03-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2003-248 - Rev 00
    Withdrawn by Holder
    Carvedilol
    2010-04-21
    Japanese DMF

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    Written Confirmation

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    Application Number
    18158
    R1-CEP 2003-248 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CARVEDILOL, MICRONIZED
    Carvedilol
    Issue/Submission Date
    2005-03-11
    2010-04-21
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    Ivabradine Hydrochloride

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    USDMF

    Found USDMF

    33213
    Active
    IVABRADINE HYDROCHLORIDE (FORM IV)
    2018-10-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    33213
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IVABRADINE HYDROCHLORIDE (FORM IV)
    Issue/Submission Date
    2018-10-15
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    Olopatadine Hydrochloride

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    USDMF

    Found USDMF

    19417
    Active
    OLOPATADINE HYDROCHLORIDE
    2006-05-09
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    19417
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OLOPATADINE HYDROCHLORIDE
    Issue/Submission Date
    2006-05-09
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    Triflusal

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-032 - Rev 04
    Valid
    Triflusal
    2019-08-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2000-032 - Rev 04
    Status
    Valid
     
    Filing Details
    Triflusal
    Issue/Submission Date
    2019-08-14
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