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

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Modafinil

    ACTIVE PHARMA INGREDIENTS

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    01

    WATSON LABS INC

    Ireland
    BioProcess International
    Not Confirmed
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    WATSON LABS INC

    Ireland
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    BioProcess International
    Not Confirmed
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    RLD : No

    TE Code : AB

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2012-11-01

    Application Number : 76715

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    WATSON LABS INC

    Ireland
    BioProcess International
    Not Confirmed
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    WATSON LABS INC

    Ireland
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    BioProcess International
    Not Confirmed
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    RLD : No

    TE Code : AB

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2012-11-01

    Application Number : 76715

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    BARR

    U.S.A
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    RLD :

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : Tablet; Oral

    Dosage Strength : 100MG

    Approval Date :

    Application Number : 76597

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    BARR

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    RLD :

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : Tablet; Oral

    Dosage Strength : 200MG

    Approval Date :

    Application Number : 76597

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    05

    CEPHALON

    U.S.A
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    RLD : Yes

    TE Code : AB

    MODAFINIL

    Brand Name : PROVIGIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 1998-12-24

    Application Number : 20717

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    CEPHALON

    U.S.A
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    RLD : Yes

    TE Code : AB

    MODAFINIL

    Brand Name : PROVIGIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 1998-12-24

    Application Number : 20717

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    TEVA PHARMS

    Israel
    BioProcess International
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    RLD :

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET; ORAL

    Dosage Strength : 100MG

    Approval Date :

    Application Number : 76596

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    08

    TEVA PHARMS

    Israel
    BioProcess International
    Not Confirmed
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    TEVA PHARMS

    Israel
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    RLD :

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET; ORAL

    Dosage Strength : 200MG

    Approval Date :

    Application Number : 76596

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    09

    MYLAN PHARMS INC

    U.S.A
    BioProcess International
    Not Confirmed
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    MYLAN PHARMS INC

    U.S.A
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    BioProcess International
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    RLD : No

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2012-07-16

    Application Number : 76594

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    MYLAN PHARMS INC

    U.S.A
    BioProcess International
    Not Confirmed
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    MYLAN PHARMS INC

    U.S.A
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    MODAFINIL

    Brand Name : MODAFINIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2012-07-16

    Application Number : 76594

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

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    Website

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