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    Approved Drug Products containing 21485 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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    Orion Corporation

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    01

    Brand Name : STALEVO 75

    Finland
    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 75

    Dosage Strength : 18.75MG;200MG;75MG

    Approval Date : 2008-08-29

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    02

    Brand Name : STALEVO 150

    Finland
    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 150

    Dosage Strength : 37.5MG;200MG;150MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    03

    Brand Name : STALEVO 50

    Finland
    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 50

    Dosage Strength : 12.5MG;200MG;50MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    04

    Brand Name : STALEVO 125

    Finland
    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 125

    Dosage Strength : 31.25MG;200MG;125MG

    Approval Date : 2008-08-29

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    05

    Brand Name : STALEVO 200

    Finland
    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 200

    Dosage Strength : 50MG;200MG;200MG

    Approval Date : 2007-08-02

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    Brand Name : STALEVO 100

    Finland
    Discovery on Target
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 100

    Dosage Strength : 25MG;200MG;100MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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