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

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    Minbiotech Ferric Carboxymaltose

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Ferric Carboxymaltose

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    01

    AM REGENT

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    RLD : Yes

    TE Code :

    FERRIC CARBOXYMALTOSE

    Brand Name : INJECTAFER

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 750MG IRON/15ML (50MG IRON/ML)

    Approval Date : 2013-07-25

    Application Number : 203565

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    U.S.A
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    RLD : Yes

    TE Code :

    FERRIC CARBOXYMALTOSE

    Brand Name : INJECTAFER

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 500MG IRON/10ML (50MG IRON/ML)

    Approval Date : 2020-10-08

    Application Number : 203565

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    AM REGENT

    U.S.A
    FNCE 2024
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    Not Confirmed
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    RLD : Yes

    TE Code :

    FERRIC CARBOXYMALTOSE

    Brand Name : INJECTAFER

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 1GM IRON/20ML (50MG IRON/ML)

    Approval Date : 2021-04-28

    Application Number : 203565

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    AM REGENT

    U.S.A
    FNCE 2024
    Not Confirmed
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    AM REGENT

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    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code :

    FERRIC CARBOXYMALTOSE

    Brand Name : INJECTAFER

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 100MG IRON/2ML (50MG IRON/ML)

    Approval Date : 2022-02-04

    Application Number : 203565

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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