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    Approved Drug Products containing Hydroxyurea listed in the FDA Orange Book. Original Data : FDA Website

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    Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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    SPI Pharma has been solving formulation challenges using superior functional materials.

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    xyz-pharma-m-2024-10-07

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    Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Hydroxyurea

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    01 3BARR

    02 2BARR LABS INC

    03 4CHEPLAPHARM

    04 1ENDO OPERATIONS

    05 1LEADING

    06 1NOVA LABS LTD

    07 1QILU

    08 1ROXANE

    09 2THERAVIA

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    01

    BARR LABS INC

    U.S.A
    AAPS 2024
    Not Confirmed
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    BARR LABS INC

    U.S.A
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    RLD : No

    TE Code :

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Approval Date : 1998-07-30

    Application Number : 75020

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    BARR LABS INC

    U.S.A
    AAPS 2024
    Not Confirmed
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    BARR LABS INC

    U.S.A
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    RLD : No

    TE Code :

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

    Approval Date : 2000-06-26

    Application Number : 75020

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    BARR

    U.S.A
    AAPS 2024
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    RLD : No

    TE Code : AB

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Approval Date : 1998-10-16

    Application Number : 75143

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    BARR

    U.S.A
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    RLD : No

    TE Code :

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

    Approval Date : 2000-09-21

    Application Number : 75143

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    CHEPLAPHARM

    Germany
    AAPS 2024
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    CHEPLAPHARM

    Germany
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    RLD : Yes

    TE Code : AB

    HYDROXYUREA

    Brand Name : HYDREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Approval Date : 1982-01-01

    Application Number : 16295

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    CHEPLAPHARM

    Germany
    AAPS 2024
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    CHEPLAPHARM

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    RLD : Yes

    TE Code :

    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Approval Date : 1998-02-25

    Application Number : 16295

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    CHEPLAPHARM

    Germany
    AAPS 2024
    Not Confirmed
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    CHEPLAPHARM

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    RLD : Yes

    TE Code :

    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 300MG

    Approval Date : 1998-02-25

    Application Number : 16295

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    CHEPLAPHARM

    Germany
    AAPS 2024
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    CHEPLAPHARM

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    RLD : Yes

    TE Code :

    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 400MG

    Approval Date : 1998-02-25

    Application Number : 16295

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    09

    ROXANE

    U.S.A
    AAPS 2024
    Not Confirmed
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    ROXANE

    U.S.A
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    RLD : No

    TE Code :

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Approval Date : 1995-08-18

    Application Number : 74476

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    ENDO OPERATIONS

    Country
    AAPS 2024
    Not Confirmed
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    ENDO OPERATIONS

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    RLD : No

    TE Code : AB

    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

    Approval Date : 1999-02-24

    Application Number : 75340

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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