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    Sodium Phenylbutyrate

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    05 2Horizon Therapeutics

    06 1LUCANE PHARMA SA

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    Horizon Therapeutics

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    SODIUM PHENYLBUTYRATE

    Brand Name : BUPHENYL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1996-05-13

    Application Number : 20572

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    Horizon Therapeutics

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    SODIUM PHENYLBUTYRATE

    Brand Name : BUPHENYL

    Dosage Form : POWDER;ORAL

    Dosage Strength : 3GM/TEASPOONFUL

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    Approval Date : 1996-04-30

    Application Number : 20573

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    MEDUNIK CANADA

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    SODIUM PHENYLBUTYRATE

    Brand Name : PHEBURANE

    Dosage Form : PELLETS;ORAL

    Dosage Strength : 84GM/BOT

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    Approval Date : 2022-06-17

    Application Number : 216513

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    MEDUNIK CANADA

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    SODIUM PHENYLBUTYRATE

    Brand Name : PHEBURANE

    Dosage Form : GRANULES

    Dosage Strength : 483MG/G

    Packaging : 174G

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    Application Number : 2436663

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    Registration Country : Canada

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    NordMedica

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    Sodium phenylbutyrate

    Brand Name : Pheburane

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    Orpharma

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    sodium phenylbutyrate

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    Sigmapharm Laboratories, LLC

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    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 3GM/TEASPOONFUL

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    Approval Date : 2013-03-22

    Application Number : 202819

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    Swedish Orphan Biovitrum AB

    Sweden
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    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Sodium Phenylbutyrate 500Mg 250 Unita' Oral Use

    Dosage Strength : 250 CPR 500 mg bottle

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    Brand Name : Ammonaps

    Dosage Form : Sodium Phenylbutyrate 266G 940Mg/G Oral Use

    Dosage Strength : os granulate for suspension 266 g 940 mg/g

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    Swedish Orphan Biovitrum AB

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    Registration Country : Norway

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    Brand Name : Ammonaps

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 500 mg

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    Swedish Orphan Biovitrum AB

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    Brand Name : Ammonaps

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    Registration Country : Norway

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    Tobio Novelfarma

    Turkey
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    Regulatory Info : Lic. No- 24.12.2020/2020-272

    Registration Country : Turkey

    Sodium Phenylbutyrate

    Brand Name : HIPER-AMONEMIX

    Dosage Form : Granules

    Dosage Strength : 940MG/1G

    Packaging : 266 g/ Bottle

    Approval Date :

    Application Number :

    Regulatory Info : Lic. No- 24.12.2020/2020-272

    Registration Country : Turkey

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    Tobio Novelfarma

    Turkey
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    Regulatory Info : Lic. No- 24.12.2020/2020-272

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    Sodium Phenylbutyrate

    Brand Name : HIPER-AMONEMIX

    Dosage Form : Granules

    Dosage Strength : 940MG/1G

    Packaging : 266 g/ Bottle

    Approval Date :

    Application Number :

    Regulatory Info : Lic. No- 24.12.2020/2020-272

    Registration Country : Turkey

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    ENDO OPERATIONS

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    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 3GM/TEASPOONFUL

    Packaging :

    Approval Date : 2016-06-15

    Application Number : 203918

    Regulatory Info : RX

    Registration Country : USA

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    ENDO OPERATIONS

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    SODIUM PHENYLBUTYRATE

    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2016-04-15

    Application Number : 204395

    Regulatory Info : RX

    Registration Country : USA

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    LUCANE PHARMA SA

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    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    Brand Name : Pheburane

    Dosage Form : Sodium Phenylbutyrate 174G 483Mg/G Oral Use

    Dosage Strength : os grat suspe 174 g 483 mg/g

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    Regulatory Info :

    Registration Country : Italy

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    Lucane Pharma

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    Regulatory Info :

    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Pheburane

    Dosage Form : Granules

    Dosage Strength : 483 mg/g

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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