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    01 2Adamed Pharma

    02 2Aurobindo Pharma Limited

    03 2BIOFUTURA PHARMA SpA

    04 2Chartwell Pharmaceuticals llc

    05 4Hikma Pharmaceuticals

    06 2Meda Pharmaceuticals Inc.

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    Aurobindo Pharma Limited

    India
    AMWC Asia-TDAC
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    Aurobindo Pharma Limited

    India
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

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    Approval Date : 2008-06-06

    Application Number : 78829

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    Registration Country : USA

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    Aurobindo Pharma Limited

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

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    Approval Date : 2008-06-06

    Application Number : 78829

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    03

    Chartwell Pharmaceuticals llc

    U.S.A
    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

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    Approval Date : 2008-06-20

    Application Number : 77505

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    04

    Chartwell Pharmaceuticals llc

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

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    Approval Date : 2008-06-20

    Application Number : 77505

    Regulatory Info : RX

    Registration Country : USA

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    05

    Hikma Pharmaceuticals

    United Kingdom
    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

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    Approval Date : 2008-06-06

    Application Number : 77237

    Regulatory Info : RX

    Registration Country : USA

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    06

    Hikma Pharmaceuticals

    United Kingdom
    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

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    Approval Date : 2008-06-06

    Application Number : 77237

    Regulatory Info : RX

    Registration Country : USA

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    07

    Hikma Pharmaceuticals

    United Kingdom
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-11-25

    Application Number : 78147

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Hikma Pharmaceuticals

    United Kingdom
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-11-25

    Application Number : 78147

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Natco Pharma

    India
    AMWC Asia-TDAC
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    Natco Pharma

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 77238

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Natco Pharma

    India
    AMWC Asia-TDAC
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    Natco Pharma

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 77238

    Regulatory Info : DISCN

    Registration Country : USA

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    11

    Pfizer Inc

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    ZALEPLON

    Brand Name : SONATA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 1999-08-13

    Application Number : 20859

    Regulatory Info : RX

    Registration Country : USA

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    12

    Pfizer Inc

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    AMWC Asia-TDAC
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    Regulatory Info : RX

    Registration Country : USA

    ZALEPLON

    Brand Name : SONATA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 1999-08-13

    Application Number : 20859

    Regulatory Info : RX

    Registration Country : USA

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    13

    Teva Pharmaceutical Industries

    Israel
    AMWC Asia-TDAC
    Not Confirmed
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    Teva Pharmaceutical Industries

    Israel
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    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 77239

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Teva Pharmaceutical Industries

    Israel
    AMWC Asia-TDAC
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    Teva Pharmaceutical Industries

    Israel
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    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 77239

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    Unichem Pharmaceuticals USA, Inc

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Unichem Pharmaceuticals USA, Inc

    U.S.A
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78989

    Regulatory Info : RX

    Registration Country : USA

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    16

    Unichem Pharmaceuticals USA, Inc

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Unichem Pharmaceuticals USA, Inc

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    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78989

    Regulatory Info : RX

    Registration Country : USA

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    17

    Upsher-Smith Laboratories

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Upsher-Smith Laboratories

    U.S.A
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    AMWC Asia-TDAC
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78095

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Upsher-Smith Laboratories

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Upsher-Smith Laboratories

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78095

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Upsher-Smith Laboratories

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Upsher-Smith Laboratories

    U.S.A
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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78706

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    Upsher-Smith Laboratories

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    Upsher-Smith Laboratories

    U.S.A
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    AMWC Asia-TDAC
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    Regulatory Info : DISCN

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    ZALEPLON

    Brand Name : ZALEPLON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2008-06-06

    Application Number : 78706

    Regulatory Info : DISCN

    Registration Country : USA

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