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    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Hydroxyurea (D4)

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    01

    medac

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    Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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    Regulatory Info : Approved

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    Hydroxycarbamide

    Brand Name : Hydroxyurea Medac

    Dosage Form : Capsule

    Dosage Strength : 500mg

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    Approval Date : 09/10/1998

    Application Number : 19981009000032

    Regulatory Info : Approved

    Registration Country : Sweden

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    medac

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    Regulatory Info : Authorized

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    Hydroxycarbamide

    Brand Name : Hidroxicarbamida Medac

    Dosage Form : Hard Capsule

    Dosage Strength : 500MG

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    Approval Date : 2023-12-14

    Application Number : 89193

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    03

    Accure Labs

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    Regulatory Info : Generic

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    Hydroxyurea

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    Dosage Form : CAPSULE

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    04

    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1998-07-30

    Application Number : 75020

    Regulatory Info : DISCN

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    05

    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

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    Approval Date : 2000-06-26

    Application Number : 75020

    Regulatory Info : DISCN

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    Barr Laboratories

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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1998-10-16

    Application Number : 75143

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    07

    Barr Laboratories

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

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    Approval Date : 2000-09-21

    Application Number : 75143

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    08

    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 1GM

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    Approval Date : 2000-08-29

    Application Number : 75734

    Regulatory Info : DISCN

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    09

    Flagship Biotech International Pvt....

    India
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    Hydroxyurea

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    Dosage Form : Capsule

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    Regulatory Info : Generic

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    10

    Leading Pharma, LLC

    U.S.A
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 2020-04-08

    Application Number : 213438

    Regulatory Info : RX

    Registration Country : USA

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    11

    Nova Laboratories

    United Kingdom
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : XROMI

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 100MG/ML

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    Approval Date : 2024-04-04

    Application Number : 216593

    Regulatory Info : RX

    Registration Country : USA

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    12

    Qilu Pharmaceutical

    China
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    Qilu Pharmaceutical

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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 2024-03-06

    Application Number : 218021

    Regulatory Info : RX

    Registration Country : USA

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    13

    ROXANE

    U.S.A
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    ROXANE

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 1995-08-18

    Application Number : 74476

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Theravia

    France
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    Theravia

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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : SIKLOS

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2017-12-21

    Application Number : 208843

    Regulatory Info : RX

    Registration Country : USA

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    15

    Theravia

    France
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    Theravia

    France
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    HYDROXYUREA

    Brand Name : SIKLOS

    Dosage Form : TABLET;ORAL

    Dosage Strength : 1GM

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    Approval Date : 2017-12-21

    Application Number : 208843

    Regulatory Info : RX

    Registration Country : USA

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    16

    Waylis Therapeutics

    U.S.A
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    Waylis Therapeutics

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    HYDROXYUREA

    Brand Name : HYDREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1982-01-01

    Application Number : 16295

    Regulatory Info : RX

    Registration Country : USA

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    17

    Waylis Therapeutics

    U.S.A
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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 1998-02-25

    Application Number : 16295

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Waylis Therapeutics

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 300MG

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    Approval Date : 1998-02-25

    Application Number : 16295

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Waylis Therapeutics

    U.S.A
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    Waylis Therapeutics

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 400MG

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    Approval Date : 1998-02-25

    Application Number : 16295

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    PH HEALTH

    Country
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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 1999-02-24

    Application Number : 75340

    Regulatory Info : RX

    Registration Country : USA

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