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    Sodium Phenylbutyrate

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    01 6Acer Therapeutics

    02 1Alvogen

    03 2Amgen Inc

    04 2Endo International

    05 1Glenmark Pharmaceuticals

    06 1LUCANE PHARMA SA

    07 1Lucane Pharma

    08 2MEDUNIK CANADA

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    01

    Acer Therapeutics

    U.S.A
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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 2GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

    Regulatory Info : RX

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    02

    Acer Therapeutics

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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 3GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

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    03

    Acer Therapeutics

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    Regulatory Info : RX

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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 4GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

    Regulatory Info : RX

    Registration Country : USA

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    04

    Acer Therapeutics

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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 5GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

    Regulatory Info : RX

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    05

    Acer Therapeutics

    U.S.A
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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 6GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

    Regulatory Info : RX

    Registration Country : USA

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    06

    Acer Therapeutics

    U.S.A
    BIO Asia-Taiwan
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    Acer Therapeutics

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    SODIUM PHENYLBUTYRATE

    Brand Name : OLPRUVA

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 6.67GM/PACKET

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    Approval Date : 2022-12-22

    Application Number : 214860

    Regulatory Info : RX

    Registration Country : USA

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    07

    Alvogen

    U.S.A
    BIO Asia-Taiwan
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    Alvogen

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    Regulatory Info : DISCN

    Registration Country : USA

    SODIUM PHENYLBUTYRATE

    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

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    Approval Date : 2011-11-18

    Application Number : 90910

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Amgen Inc

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    BIO Asia-Taiwan
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    Amgen Inc

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    Regulatory Info : RX

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    SODIUM PHENYLBUTYRATE

    Brand Name : BUPHENYL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 1996-05-13

    Application Number : 20572

    Regulatory Info : RX

    Registration Country : USA

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    09

    Amgen Inc

    U.S.A
    BIO Asia-Taiwan
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    Amgen Inc

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    BIO Asia-Taiwan
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    Regulatory Info : RX

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    SODIUM PHENYLBUTYRATE

    Brand Name : BUPHENYL

    Dosage Form : POWDER;ORAL

    Dosage Strength : 3GM/TEASPOONFUL

    Packaging :

    Approval Date : 1996-04-30

    Application Number : 20573

    Regulatory Info : RX

    Registration Country : USA

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    10

    Endo International

    Ireland
    BIO Asia-Taiwan
    Not Confirmed
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    Endo International

    Ireland
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    BIO Asia-Taiwan
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    Regulatory Info : RX

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    SODIUM PHENYLBUTYRATE

    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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    11

    Endo International

    Ireland
    BIO Asia-Taiwan
    Not Confirmed
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    Endo International

    Ireland
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    BIO Asia-Taiwan
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    Regulatory Info : RX

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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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    12

    Glenmark Pharmaceuticals

    India
    BIO Asia-Taiwan
    Not Confirmed
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    Glenmark Pharmaceuticals

    India
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    BIO Asia-Taiwan
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    Regulatory Info : RX

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    SODIUM PHENYLBUTYRATE

    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2022-11-01

    Application Number : 216462

    Regulatory Info : RX

    Registration Country : USA

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    13

    MEDUNIK CANADA

    Canada
    BIO Asia-Taiwan
    Not Confirmed
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    MEDUNIK CANADA

    Canada
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    BIO Asia-Taiwan
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    Regulatory Info : RX

    Registration Country : USA

    SODIUM PHENYLBUTYRATE

    Brand Name : PHEBURANE

    Dosage Form : PELLETS;ORAL

    Dosage Strength : 84GM/BOT

    Packaging :

    Approval Date : 2022-06-17

    Application Number : 216513

    Regulatory Info : RX

    Registration Country : USA

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    14

    Sigmapharm Laboratories, LLC

    U.S.A
    BIO Asia-Taiwan
    Not Confirmed
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    Sigmapharm Laboratories, LLC

    U.S.A
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    BIO Asia-Taiwan
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    Regulatory Info : RX

    Registration Country : USA

    SODIUM PHENYLBUTYRATE

    Brand Name : SODIUM PHENYLBUTYRATE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 3GM/TEASPOONFUL

    Packaging :

    Approval Date : 2013-03-22

    Application Number : 202819

    Regulatory Info : RX

    Registration Country : USA

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    15

    Swedish Orphan Biovitrum AB

    Sweden
    BIO Asia-Taiwan
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    BIO Asia-Taiwan
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    Regulatory Info :

    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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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    16

    Swedish Orphan Biovitrum AB

    Sweden
    BIO Asia-Taiwan
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    BIO Asia-Taiwan
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    Registration Country : Italy

    Sodium 4-Phenylbutyrate

    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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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    17

    Swedish Orphan Biovitrum AB

    Sweden
    BIO Asia-Taiwan
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    BIO Asia-Taiwan
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    Regulatory Info :

    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 500 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    18

    Swedish Orphan Biovitrum AB

    Sweden
    BIO Asia-Taiwan
    Not Confirmed
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    Swedish Orphan Biovitrum AB

    Sweden
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    BIO Asia-Taiwan
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    Registration Country : Norway

    Sodium 4-Phenylbutyrate

    Brand Name : Ammonaps

    Dosage Form : Granules

    Dosage Strength : 940 mg/g

    Packaging : Bottle

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    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    19

    LUCANE PHARMA SA

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    LUCANE PHARMA SA

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    Regulatory Info :

    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

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    20

    Lucane Pharma

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    BIO Asia-Taiwan
    Not Confirmed
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    BIO Asia-Taiwan
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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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