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

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    Bora Pharmaceuticals- Making success more certain.

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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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    Gadobutrol

    ACTIVE PHARMA INGREDIENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

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    01 6BAYER HLTHCARE

    02 2HAINAN POLY PHARM

    03 10HENGRUI PHARMA

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    01

    BAYER HLTHCARE

    Germany
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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 4.5354GM/7.5ML (604.72MG/ML)

    Approval Date : 2011-03-14

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    BAYER HLTHCARE

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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 6.0472GM/10ML (604.72MG/ML)

    Approval Date : 2011-03-14

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 9.0708GM/15ML (604.72MG/ML)

    Approval Date : 2011-03-14

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 18.1416GM/30ML (604.72MG/ML)

    Approval Date : 2011-03-14

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 39.3068GM/65ML (604.72MG/ML)

    Approval Date : 2011-03-14

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    RLD : Yes

    TE Code : AP

    GADOBUTROL

    Brand Name : GADAVIST

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 1.20944GM/2ML (604.72MG/ML)

    Approval Date : 2013-12-18

    Application Number : 201277

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    RLD :

    TE Code :

    GADOBUTROL

    Brand Name : GADOBUTROL

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 1.20944GM/2ML (604.72MG/ML)

    Approval Date :

    Application Number : 215061

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD :

    TE Code :

    GADOBUTROL

    Brand Name : GADOBUTROL

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 4.5354GM/7.5ML (604.72MG/ML)

    Approval Date :

    Application Number : 215061

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    HENGRUI PHARMA

    China
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    RLD :

    TE Code :

    GADOBUTROL

    Brand Name : GADOBUTROL

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 6.0472GM/10ML (604.72MG/ML)

    Approval Date :

    Application Number : 215061

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    10

    HENGRUI PHARMA

    China
    Luxepack
    Not Confirmed
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    HENGRUI PHARMA

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    Luxepack
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    RLD :

    TE Code :

    GADOBUTROL

    Brand Name : GADOBUTROL

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 9.0708GM/15ML (604.72MG/ML)

    Approval Date :

    Application Number : 215061

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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