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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Esteve Quimica, Sa

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    01 Amlodipine Besylate (2)

    02 Astemizole (1)

    03 Azelastine Hydrochloride (1)

    04 Bosentan Hydrate (1)

    05 Calcium (1)

    06 Carbidopa (1)

    07 Celecoxib (1)

    08 Citalopram Hydrobromide (1)

    09 Cizolirtine (1)

    10 Clindamycin Hydrochloride (1)

    11 Cyclopentolate Hydrochloride (1)

    12 Dabigatran Etexilate Mesylate (1)

    13 Diclofenac Potassium (1)

    14 Diclofenac Sodium (2)

    15 Duloxetine (1)

    16 Enalapril Maleate (1)

    17 Enalaprilat (1)

    18 Erlotinib Hydrochloride (1)

    19 Esomeprazole Sodium (1)

    20 Eszopiclone (1)

    21 Ethamsylate (1)

    22 Etofenamate (1)

    23 Felodipine (1)

    24 Fluoxetine Hydrochloride (1)

    25 Ibrutinib (1)

    26 Indomethacin (1)

    27 Ketoconazole (1)

    28 Lansoprazole (1)

    29 Lesopitron Dihydrochloride (1)

    30 Levetiracetam (2)

    31 Lisinopril (1)

    32 Lixivaptan (1)

    33 Meloxicam (1)

    34 Memantine Hydrochloride (1)

    35 Methyldopa (1)

    36 Metoprolol Fumarate (1)

    37 Metoprolol Succinate (1)

    38 Metoprolol Tartrate (1)

    39 Moexipril (1)

    40 Nabumetone (1)

    41 Nefazodone Hydrochloride (1)

    42 Omeprazole (2)

    43 Omeprazole Sodium (1)

    44 Pantoprazole Sodium (2)

    45 Pethidine Hydrochloride (2)

    46 Piroxicam (1)

    47 Quinapril (1)

    48 Ramipril (1)

    49 Riluzole (1)

    50 Solifenacin Succinate (1)

    51 Tenoxicam (1)

    52 Triflusal (1)

    53 Wy 50324 (1)

    54 Zidovudine (1)

    55 Blank (2)

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    01 Active (9)

    02 Inactive (39)

    03 Blank (14)

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    01 Expired (1)

    02 Valid (19)

    03 Withdrawn by Holder (11)

    04 Blank (31)

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    01 218MF10605 (1)

    02 220MF10248 (1)

    03 224MF10021 (1)

    04 227MF10082 (1)

    05 301MF10071 (1)

    06 Blank (57)

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    01 Blank (62)

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    Amlodipine Besylate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    15127
    Inactive
    AMLODIPINE BESILATE
    2000-11-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-073 - Rev 02
    Valid
    Amlodipine besilate
    2020-10-28
    Japanese DMF

    Found JDMF

    220MF10248
    Amlodipine besylate at Torre Esteve...
    2008-12-11
    Written Confirmation

    Close WC

    Application Number
    15127
    R1-CEP 2008-073 - Rev 02
    220MF10248
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMLODIPINE BESILATE
    Amlodipine besilate
    Amlodipine besylate at Torre Esteve...
    Issue/Submission Date
    2000-11-02
    2020-10-28
    2008-12-11
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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11017
    Inactive
    OMEPRAZOLE
    1994-08-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-145 - Rev 10
    Valid
    Omeprazole, Micronised and sieved g...
    2022-03-16
    Japanese DMF

    Found JDMF

    218MF10605
    Omeprazole at Torre Esteve, Pg. de ...
    2006-07-03
    Written Confirmation

    Close WC

    Application Number
    11017
    R1-CEP 1998-145 - Rev 10
    218MF10605
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole, Micronised and sieved g...
    Omeprazole at Torre Esteve, Pg. de ...
    Issue/Submission Date
    1994-08-02
    2022-03-16
    2006-07-03
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    22427
    Active
    AZELASTINE HYDROCHLORIDE
    2009-01-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-010 - Rev 03
    Valid
    Azelastine hydrochloride
    2020-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22427
    R1-CEP 2010-010 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZELASTINE HYDROCHLORIDE
    Azelastine hydrochloride
    Issue/Submission Date
    2009-01-20
    2020-08-17
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    Diclofenac Sodium

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    USDMF

    Found USDMF

    9115
    Active
    DICLOFENAC SODIUM
    1991-04-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-133 - Rev 07
    Valid
    Diclofenac sodium
    2020-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9115
    R1-CEP 2000-133 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DICLOFENAC SODIUM
    Diclofenac sodium
    Issue/Submission Date
    1991-04-22
    2020-06-09
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    Duloxetine

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    USDMF

    Found USDMF

    24659
    Active
    DULOXETINE HYDROCHLORIDE
    2011-02-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-016 - Rev 02
    Valid
    Duloxetine hydrochloride
    2021-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24659
    R1-CEP 2013-016 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DULOXETINE HYDROCHLORIDE
    Duloxetine hydrochloride
    Issue/Submission Date
    2011-02-18
    2021-07-26
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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11794
    Active
    OMEPRAZOLE
    1995-12-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-022 - Rev 04
    Valid
    Omeprazole
    2020-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11794
    R1-CEP 1996-022 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Issue/Submission Date
    1995-12-21
    2020-10-28
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    Riluzole

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    USDMF

    Found USDMF

    24693
    Active
    RILUZOLE
    2011-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10021
    Riluzole at Torre Esteve, Pg. de la...
    2012-02-01
    Written Confirmation

    Close WC

    Application Number
    24693
    224MF10021
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RILUZOLE
    Riluzole at Torre Esteve, Pg. de la...
    Issue/Submission Date
    2011-02-28
    2012-02-01
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    Felodipine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    12248
    Inactive
    FELODIPINE
    1996-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-090 - Rev 05
    Valid
    Felodipine
    2019-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12248
    R1-CEP 1996-090 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FELODIPINE
    Felodipine
    Issue/Submission Date
    1996-12-04
    2019-02-15
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    Lansoprazole

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    USDMF

    Found USDMF

    19310
    Active
    LANSOPRAZOLE
    2006-03-09
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-331 - Rev 01
    Withdrawn by Holder
    Lansoprazole, Micronised
    2018-08-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19310
    R1-CEP 2007-331 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    LANSOPRAZOLE
    Lansoprazole, Micronised
    Issue/Submission Date
    2006-03-09
    2018-08-13
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    Levetiracetam

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    USDMF

    Caution USDMF

    17327
    Inactive
    LEVETIRACETAM
    2004-04-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-042 - Rev 05
    Valid
    Levetiracetam, Code product 2577
    2021-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17327
    R1-CEP 2011-042 - Rev 05
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LEVETIRACETAM
    Levetiracetam, Code product 2577
    Issue/Submission Date
    2004-04-26
    2021-06-15
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