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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Zaleplon

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    Adamed Pharma

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    Aurobindo Pharma Limited

    India
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    Approval Date : 2008-06-06

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    Aurobindo Pharma Limited

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    Chartwell Pharmaceuticals llc

    U.S.A
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    Approval Date : 2008-06-20

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    Chartwell Pharmaceuticals llc

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    07

    Hikma Pharmaceuticals

    United Kingdom
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    Approval Date : 2008-06-06

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    Hikma Pharmaceuticals

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    09

    Hikma Pharmaceuticals

    United Kingdom
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    Approval Date : 2008-11-25

    Application Number : 78147

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    10

    Hikma Pharmaceuticals

    United Kingdom
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    Approval Date : 2008-11-25

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    11

    Meda Pharmaceuticals Inc.

    U.S.A
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    12

    Natco Pharma

    India
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    ZALEPLON

    Brand Name : ZALEPLON

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    Approval Date : 2008-06-06

    Application Number : 77238

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Natco Pharma

    India
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    Approval Date : 2008-06-06

    Application Number : 77238

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    14

    OrBion Pharmaceuticals

    India
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    ZALEPLON

    Brand Name : ZALEPLON

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    Approval Date : 2009-09-17

    Application Number : 90374

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    Registration Country : USA

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    15

    OrBion Pharmaceuticals

    India
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    Approval Date : 2009-09-17

    Application Number : 90374

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    16

    Orchid Pharma

    India
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    17

    Orchid Pharma

    India
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    18

    Pfizer Inc

    U.S.A
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    ZALEPLON

    Brand Name : SONATA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

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    Approval Date : 1999-08-13

    Application Number : 20859

    Regulatory Info : RX

    Registration Country : USA

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    19

    Pfizer Inc

    U.S.A
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    Brand Name : SONATA

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    Approval Date : 1999-08-13

    Application Number : 20859

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    Registration Country : USA

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    20

    Teva Pharmaceutical Industries

    Israel
    Immuno-Oncology 360
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    Israel
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    ZALEPLON

    Brand Name : ZALEPLON

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    Dosage Strength : 5MG

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    Approval Date : 2008-06-06

    Application Number : 77239

    Regulatory Info : DISCN

    Registration Country : USA

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    21

    Teva Pharmaceutical Industries

    Israel
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    Israel
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    Brand Name : ZALEPLON

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    Approval Date : 2008-06-06

    Application Number : 77239

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    Registration Country : USA

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    22

    Unichem Laboratories Limited

    India
    Immuno-Oncology 360
    Not Confirmed
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    India
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    23

    Unichem Laboratories Limited

    India
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    India
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    24

    Unichem Pharmaceuticals USA, Inc

    U.S.A
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    Not Confirmed
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    U.S.A
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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 : 78989

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    Registration Country : USA

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    Unichem Pharmaceuticals USA, Inc

    U.S.A
    Immuno-Oncology 360
    Not Confirmed
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    Unichem Pharmaceuticals USA, Inc

    U.S.A
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    Registration Country : USA

    ZALEPLON

    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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    26

    Upsher-Smith Laboratories

    U.S.A
    Immuno-Oncology 360
    Not Confirmed
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    Upsher-Smith Laboratories

    U.S.A
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    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    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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    27

    Upsher-Smith Laboratories

    U.S.A
    Immuno-Oncology 360
    Not Confirmed
    arrow

    Upsher-Smith Laboratories

    U.S.A
    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    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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    28

    Upsher-Smith Laboratories

    U.S.A
    Immuno-Oncology 360
    Not Confirmed
    arrow

    Upsher-Smith Laboratories

    U.S.A
    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    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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    29

    Upsher-Smith Laboratories

    U.S.A
    Immuno-Oncology 360
    Not Confirmed
    arrow

    Upsher-Smith Laboratories

    U.S.A
    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    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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    30

    BIOFUTURA PHARMA SpA

    Country
    Immuno-Oncology 360
    Not Confirmed
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    BIOFUTURA PHARMA SpA

    Country
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    Immuno-Oncology 360
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Zaleplon

    Brand Name : Zerene

    Dosage Form :

    Dosage Strength : 14 Cps 5 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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