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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Amsa Spa

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    01 Amantadine Hydrochloride (1)

    02 Anagrelide Hydrochloride (1)

    03 Atenolol (1)

    04 Bromhexine Hydrochloride (1)

    05 Carteolol (1)

    06 Diclofenac (1)

    07 Etodolac (1)

    08 Fenofibrate (1)

    09 Flecainide (1)

    10 Glipizide (1)

    11 Glycopyrronium Bromide (1)

    12 Glycopyrronium Tosylate (1)

    13 Levodropropizine (1)

    14 Lurasidone Hydrochloride (1)

    15 Meloxicam (1)

    16 Memantine Hydrochloride (1)

    17 Metoclopramide (1)

    18 Metoclopramide Dihydrochloride (1)

    19 Metoclopramide Hydrochloride (1)

    20 Oxantel Pamoate (1)

    21 Phenylbutazone (1)

    22 Tolmetin Sodium (1)

    23 Blank (1)

    filter

    01 Active (9)

    02 Inactive (7)

    03 Blank (7)

    filter

    01 Valid (3)

    02 Blank (20)

    filter

    01 218MF11036 (1)

    02 221MF10057 (1)

    03 223MF10093 (1)

    04 302MF10148 (1)

    05 305MF10087 (1)

    06 Blank (18)

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    01 Blank (23)

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    • FDA
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    Flecainide

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    USDMF

    Found USDMF

    14749
    Active
    FLECAINIDE ACETATE
    2000-02-29
    CEP/COS

    Found CEP/COS

    CEP 2009-363 - Rev 03
    Valid
    Flecainide acetate
    2023-12-06
    Japanese DMF

    Found JDMF

    223MF10093
    Flecainide acetate at VIALE DEL GHI...
    2011-06-29
    Written Confirmation

    Close WC

    Application Number
    14749
    CEP 2009-363 - Rev 03
    223MF10093
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLECAINIDE ACETATE
    Flecainide acetate
    Flecainide acetate at VIALE DEL GHI...
    Issue/Submission Date
    2000-02-29
    2023-12-06
    2011-06-29
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    • FDA
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    16972
    Active
    GLYCOPYRROLATE
    2003-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-194 - Rev 01
    Valid
    Glycopyrronium bromide
    2021-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16972
    R1-CEP 2014-194 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCOPYRROLATE
    Glycopyrronium bromide
    Issue/Submission Date
    2003-11-13
    2021-02-18
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    Meloxicam

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    USDMF

    Found USDMF

    17238
    Active
    MELOXICAM
    2004-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF11036
    Meloxicam at VIALE DEL GHISALLO, 20...
    2006-12-28
    Written Confirmation

    Close WC

    Application Number
    17238
    218MF11036
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MELOXICAM
    Meloxicam at VIALE DEL GHISALLO, 20...
    Issue/Submission Date
    2004-03-16
    2006-12-28
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    Amantadine Hydrochloride

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    USDMF

    Found USDMF

    29486
    Active
    AMANTADINE HYDROCHLORIDE
    2015-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    29486
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMANTADINE HYDROCHLORIDE
    Issue/Submission Date
    2015-09-01
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    Diclofenac

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    USDMF

    Found USDMF

    14831
    Active
    DICLOFENAC HYDROXY ETHYL PYRROLIDIN...
    2000-04-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    14831
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DICLOFENAC HYDROXY ETHYL PYRROLIDIN...
    Issue/Submission Date
    2000-04-10
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    Etodolac

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    USDMF

    Found USDMF

    11359
    Active
    ETODOLAC
    1995-02-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11359
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ETODOLAC
    Issue/Submission Date
    1995-02-20
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    Glipizide

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    USDMF

    Found USDMF

    13101
    Active
    GLIPIZIDE
    1998-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    13101
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLIPIZIDE
    Issue/Submission Date
    1998-07-30
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    Glycopyrronium Tosylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10148
    Glycopyrronium tosylate monohydrate...
    2020-12-15
    Written Confirmation

    Close WC

    Application Number
    302MF10148
    Status
     
    Filing Details
    Glycopyrronium tosylate monohydrate...
    Issue/Submission Date
    2020-12-15
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    Levodropropizine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-121 - Rev 00
    Valid
    Levodropropizine
    2020-03-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-121 - Rev 00
    Status
    Valid
     
    Filing Details
    Levodropropizine
    Issue/Submission Date
    2020-03-31
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    Lurasidone Hydrochloride

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    USDMF

    Found USDMF

    27898
    Active
    LURASIDONE HYDROCHLORIDE
    2014-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    27898
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2014-04-30
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