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    Approved Drug Products of Avyxa listed in the FDA Orange Book. Original Data : FDA Website

    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Avyxa

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    FINISHED DOSAGE FORMULATIONS

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    02 4DOCETAXEL

    03 2PALONOSETRON HYDROCHLORIDE

    04 2PEMETREXED DIPOTASSIUM

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    RLD : Yes

    TE Code :

    CYCLOPHOSPHAMIDE

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : CYCLOPHOSPHAMIDE

    Dosage Strength : 500MG/ML (500MG/ML)

    Approval Date : 2023-06-07

    Application Number : 210852

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    RLD : Yes

    TE Code :

    CYCLOPHOSPHAMIDE

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : CYCLOPHOSPHAMIDE

    Dosage Strength : 1GM/2ML (500MG/ML)

    Approval Date : 2023-06-07

    Application Number : 210852

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    RLD : Yes

    TE Code :

    CYCLOPHOSPHAMIDE

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : CYCLOPHOSPHAMIDE

    Dosage Strength : 2GM/4ML (500MG/ML)

    Approval Date : 2023-06-07

    Application Number : 210852

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code :

    DOCETAXEL

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : DOCIVYX

    Dosage Strength : 20MG/2ML (10MG/ML)

    Approval Date : 2022-11-22

    Application Number : 215813

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code :

    DOCETAXEL

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : DOCIVYX

    Dosage Strength : 80MG/8ML (10MG/ML)

    Approval Date : 2022-11-22

    Application Number : 215813

    RX/OTC/DISCN : RX

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    RLD : Yes

    TE Code :

    DOCETAXEL

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : DOCIVYX

    Dosage Strength : 160MG/16ML (10MG/ML)

    Approval Date : 2022-11-22

    Application Number : 215813

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD :

    TE Code :

    DOCETAXEL

    Avyxa

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : DOCETAXEL

    Dosage Strength : 160MG/16ML

    Approval Date :

    Application Number : 215813

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD : Yes

    TE Code :

    PALONOSETRON HYDROCHLORIDE

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : POSFREA

    Dosage Strength : EQ 0.075MG BASE/1.5ML (E...

    Approval Date : 2016-03-01

    Application Number : 203050

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    RLD : Yes

    TE Code :

    PALONOSETRON HYDROCHLORIDE

    Avyxa

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : POSFREA

    Dosage Strength : EQ 0.25MG BASE/5ML (EQ 0...

    Approval Date : 2016-03-01

    Application Number : 203050

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    RLD : Yes

    TE Code :

    PEMETREXED DIPOTASSIUM

    Avyxa

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : PEMETREXED

    Dosage Strength : EQ 100MG BASE/VIAL

    Approval Date : 2024-06-28

    Application Number : 210661

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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