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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alkermes Plc

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    01 Dead On Polystyrene (1)

    02 Dimethyl Sulfoxide (1)

    03 Dl-Threo-3,4-Dihydroxyphenylserine (1)

    04 Fluvoxamine (1)

    05 Glycolide - lactide copolymer (1)

    06 Meloxicam (2)

    07 Morphine Sulfate (1)

    08 Sirolimus (1)

    09 Blank (5)

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    01 Active (4)

    02 Inactive (9)

    03 Blank (1)

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    01 Blank (14)

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    01 223MF20001 (1)

    02 225MF10176 (1)

    03 Blank (12)

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    01 Blank (14)

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    Sirolimus

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    USDMF

    Found USDMF

    12571
    Active
    RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
    1997-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10176
    Rapamycin NanoCrystal Colloidal Dis...
    2013-09-18
    Written Confirmation

    Close WC

    Application Number
    12571
    225MF10176
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
    Rapamycin NanoCrystal Colloidal Dis...
    Issue/Submission Date
    1997-07-09
    2013-09-18
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    Dead On Polystyrene

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    USDMF

    Found USDMF

    29273
    Active
    POLYMILL ® POLYSTYRENE MILLING MED...
    2015-07-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    29273
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    POLYMILL ® POLYSTYRENE MILLING MED...
    Issue/Submission Date
    2015-07-15
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    Dimethyl Sulfoxide

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    USDMF

    Found USDMF

    22739
    Active
    MICROSPHERE DILUENT
    2009-05-05
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    22739
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MICROSPHERE DILUENT
    Issue/Submission Date
    2009-05-05
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    Glycolide - lactide copolymer

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF20001
    Medisorb 5050 DL 4AP at 852 Winter ...
    2011-03-10
    Written Confirmation

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    Application Number
    223MF20001
    Status
     
    Filing Details
    Medisorb 5050 DL 4AP at 852 Winter ...
    Issue/Submission Date
    2011-03-10
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    Meloxicam

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    USDMF

    Found USDMF

    29935
    Active
    NCD MELOXICAM BULK INTERMEDIATE
    2015-12-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    29935
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    NCD MELOXICAM BULK INTERMEDIATE
    Issue/Submission Date
    2015-12-07
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    Dl-Threo-3,4-Dihydroxyphenylserine

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    USDMF

    Caution USDMF

    22903
    Inactive
    ELN-CT-105G
    2009-06-23
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    22903
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ELN-CT-105G
    Issue/Submission Date
    2009-06-23
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    Fluvoxamine

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    USDMF

    Caution USDMF

    13957
    Inactive
    FLUVOXAMINE MALEATE CR CAPSULES
    1999-01-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    13957
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FLUVOXAMINE MALEATE CR CAPSULES
    Issue/Submission Date
    1999-01-22
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    Meloxicam

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    USDMF

    Caution USDMF

    18805
    Inactive
    MELOXICAM NANOCRYSTAL® TABLETS
    2005-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18805
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MELOXICAM NANOCRYSTAL® TABLETS
    Issue/Submission Date
    2005-09-26
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    Morphine Sulfate

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    USDMF

    Caution USDMF

    16433
    Inactive
    AVINZA((R) (MORPHINE SULFATE EXTEND...
    2003-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    16433
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    AVINZA((R) (MORPHINE SULFATE EXTEND...
    Issue/Submission Date
    2003-02-21
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    PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROS...

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    USDMF

    Caution USDMF

    14028
    Inactive
    PROLEASE DILUENT USED FOR SUSPENSIO...
    1999-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14028
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PROLEASE DILUENT USED FOR SUSPENSIO...
    Issue/Submission Date
    1999-03-18
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