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    Pitolisant Hydrochloride

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    01 1Annora Pharma

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    Annora Pharma

    India
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    PITOLISANT

    Brand Name : PITOLISANT

    Dosage Form : TABLET

    Dosage Strength : 17.8MG

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    Application Number : 218832

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    Registration Country : USA

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    Bioprojet Pharma

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    Regulatory Info : Approved

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 18mg

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    Approval Date : 22/07/2021

    Application Number : 20191110000029

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    03

    Bioprojet Pharma

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    Regulatory Info : Approved

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.5mg

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    Approval Date : 22/07/2021

    Application Number : 20191110000012

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    Bioprojet Pharma

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    Pitolisant Hydrochloride

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

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    Approval Date : 31/03/2016

    Application Number : 20140610000015

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    Bioprojet Pharma

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    Pitolisant Hydrochloride

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

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    Approval Date : 31/03/2016

    Application Number : 20151003000024

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    Registration Country : Sweden

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    Bioprojet Pharma

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    Regulatory Info : Authorized

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.5MG

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    Approval Date : 2021-11-11

    Application Number : 1211546001

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    Bioprojet Pharma

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    Pitolisant Hydrochloride

    Brand Name : Ozawade

    Dosage Form : Film Coated Tablet

    Dosage Strength : 18MG

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    Approval Date : 2021-11-11

    Application Number : 1211546002

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    Bioprojet Pharma

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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

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    Approval Date : 2016-09-03

    Application Number : 1151068001

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    Bioprojet Pharma

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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

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    Approval Date : 2016-08-03

    Application Number : 1151068002

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    Registration Country : Spain

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    10

    Harmony Biosciences

    U.S.A
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    U.S.A
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    Regulatory Info : RX

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    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 4.45MG BASE

    Packaging :

    Approval Date : 2019-08-14

    Application Number : 211150

    Regulatory Info : RX

    Registration Country : USA

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    11

    Harmony Biosciences

    U.S.A
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    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 17.8MG BASE

    Packaging :

    Approval Date : 2019-08-14

    Application Number : 211150

    Regulatory Info : RX

    Registration Country : USA

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    12

    MSN Laboratories

    India
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    PITOLISANT

    Brand Name : PITOLISANT

    Dosage Form : TABLET; FILM COATED

    Dosage Strength : 4.45MG

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    Approval Date :

    Application Number : 218873

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    Registration Country : USA

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    Future Health Pharma Gmbh

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

    Dosage Strength : 4.45mg

    Packaging :

    Approval Date : 20/12/2018

    Application Number : 67007

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Future Health Pharma Gmbh

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    Regulatory Info : Allowed

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    Pitolisant

    Brand Name : Wakix

    Dosage Form : Film Coated Tablet

    Dosage Strength : 17.8mg

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    Approval Date : 20/12/2018

    Application Number : 67007

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    15

    ENDO OPERATIONS LTD.

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    Regulatory Info : Prescription

    Registration Country : Canada

    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number : 2516241

    Regulatory Info : Prescription

    Registration Country : Canada

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    ENDO OPERATIONS LTD.

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    PITOLISANT HYDROCHLORIDE

    Brand Name : WAKIX

    Dosage Form : TABLET

    Dosage Strength : 20MG

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    Approval Date :

    Application Number : 2516268

    Regulatory Info : Prescription

    Registration Country : Canada

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