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    01 7ORION PHARMA

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    ORION PHARMA

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    RLD : Yes

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    ENTACAPONE

    Brand Name : COMTAN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 1999-10-19

    Application Number : 20796

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

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    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 50

    Dosage Form : TABLET;ORAL

    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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    ORION PHARMA

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    RLD : Yes

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    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 100

    Dosage Form : TABLET;ORAL

    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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    RLD : Yes

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    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 150

    Dosage Form : TABLET;ORAL

    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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    ORION PHARMA

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 200

    Dosage Form : TABLET;ORAL

    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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    ORION PHARMA

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    RLD : Yes

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    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 75

    Dosage Form : TABLET;ORAL

    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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    ORION PHARMA

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : STALEVO 125

    Dosage Form : TABLET;ORAL

    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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    08

    SUN PHARM

    India
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    SUN PHARM

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    RLD : No

    TE Code :

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : CARBIDOPA, LEVODOPA AND ENTACAPONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;200MG;100MG

    Approval Date : 2012-05-10

    Application Number : 79085

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    SUN PHARM

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    RLD : No

    TE Code :

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Brand Name : CARBIDOPA, LEVODOPA AND ENTACAPONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 37.5MG;200MG;150MG

    Approval Date : 2012-05-10

    Application Number : 79085

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    WOCKHARDT BIO AG

    India
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    RLD : No

    TE Code : AB

    ENTACAPONE

    Brand Name : ENTACAPONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2012-08-16

    Application Number : 78941

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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