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    Sapropterin Hydrochloride

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    01 3Dr. Reddy's Laboratories

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    05 2DR REDDY'S LABORATORIES LTD

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    Dr. Reddy's Laboratories

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2021-06-15

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    Dr. Reddy's Laboratories

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    SAPROPTERIN DIHYDROCHLORIDE

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    Dr. Reddy's Laboratories

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

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    Approval Date : 2022-05-13

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    Annora Pharma

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    Approval Date : 2022-08-18

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    Annora Pharma

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    SAPROPTERIN DIHYDROCHLORIDE

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    Dosage Strength : 500MG/PACKET

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    Approval Date : 2022-08-18

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    Annora Pharma

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

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    Approval Date : 2022-08-23

    Application Number : 215534

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    Aurobindo Pharma Limited

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    Sapropterin

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    BioMarin Pharmaceutical

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2007-12-13

    Application Number : 22181

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    09

    BioMarin Pharmaceutical

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    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

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    Approval Date : 2013-12-19

    Application Number : 205065

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    10

    BioMarin Pharmaceutical

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

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    Approval Date : 2015-10-27

    Application Number : 205065

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    11

    BioMarin Pharmaceutical

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    Registration Country : Sweden

    sapropterin dihydrochloride

    Brand Name : Kuvan

    Dosage Form : SOLUBLE TABLET

    Dosage Strength : 100 MG

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    Registration Country : Sweden

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    12

    BioMarin Pharmaceutical

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    Sapropterin Dihydrochloride

    Brand Name : Kuvan

    Dosage Form : Soluble Antic-Calc tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

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    13

    BioMarin Pharmaceutical

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    Sapropterin

    Brand Name : KUVAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 120 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    14

    BioMarin Pharmaceutical

    U.S.A
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    Sapropterin

    Brand Name : KUVAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    15

    Dipharma

    Italy
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    sapropterin 2HCl

    Brand Name : Diterin

    Dosage Form : Tablet

    Dosage Strength : 100mg

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    Registration Country : Italy

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    Dipharma

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    Sapropterin

    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Powder For Oral Solution Oral

    Dosage Strength : 100 mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Application Number :

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    Registration Country : Italy

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    17

    Dipharma

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    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Soluble Tablets

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    Packaging : 120 UNITS 100 MG - ORAL USE

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    Dipharma

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    Brand Name : SAPROPTERIN DIPHARMA

    Dosage Form : Soluble Tablets

    Dosage Strength : 100mg

    Packaging : 30 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    Dipharma

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    Sapropterindihydroklorid

    Brand Name : Sapropterin Dipharma

    Dosage Form : Powder for oral solution, solution

    Dosage Strength : 100 mg

    Packaging : Dosepose 30 1item

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    Dipharma

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    Sapropterindihydroklorid

    Brand Name : Sapropterin Dipharma

    Dosage Form : Soluble tablet

    Dosage Strength : 100 mg

    Packaging : Bottle 30item

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    Registration Country : Norway

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    Dipharma

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    Sapropterindihydroklorid

    Brand Name : Sapropterin Dipharma

    Dosage Form : Soluble tablet

    Dosage Strength : 100 mg

    Packaging : Bottle 120item

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    Registration Country : Norway

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    Dipharma

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    Sapropterindihydroklorid

    Brand Name : Sapropterin Dipharma

    Dosage Form : Powder for oral solution, solution

    Dosage Strength : 500 mg

    Packaging : Dosepose 30 1item

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    Dipharma SA

    Switzerland
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    Sapropterini dihydrochloridum

    Brand Name : Sapropterin Dipharma

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    ORIFARM GROUP AS

    Denmark
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    Sapropterindihydroklorid

    Brand Name : Kuvan

    Dosage Form : Soluble tablet

    Dosage Strength : 100 mg

    Packaging : Bottle 120item

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    PIAM Farmaceutici S.p.A

    Italy
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    PIAM Farmaceutici S.p.A

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    Registration Country : Italy

    Sapropterin

    Brand Name : ARPETRAN

    Dosage Form : Soluble Tablets

    Dosage Strength : 100 mg

    Packaging : 120 UNITS 100 MG - ORAL USE

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    Registration Country : Italy

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    Regulatory Info : RX

    Registration Country : USA

    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

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    Approval Date : 2019-05-10

    Application Number : 207200

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

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    Approval Date : 2019-08-20

    Application Number : 207207

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

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    Approval Date : 2019-08-20

    Application Number : 210027

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info :

    Registration Country : Italy

    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

    Dosage Strength : 120 cpr solub 100 mg

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    Registration Country : Italy

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    Tetrahydrobiopterin

    Brand Name : Kuvan

    Dosage Form : Sapropterina 100Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr solub 100 mg

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    Registration Country : Italy

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