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

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    Paliperidone

    ACTIVE PHARMA INGREDIENTS

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    01 4ACTAVIS LABS FL INC

    02 4AJANTA PHARMA LTD

    03 4AMNEAL PHARMS

    04 4ASCENT PHARMS INC

    05 4CSPC OUYI

    06 4INVENTIA

    07 4JANSSEN LP

    08 5JANSSEN PHARMS

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    01

    ACTAVIS LABS FL INC

    Ireland
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    RLD : No

    TE Code :

    PALIPERIDONE

    Brand Name : PALIPERIDONE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 1.5MG

    Approval Date : 2015-08-03

    Application Number : 202645

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    JANSSEN PHARMS

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    RLD : Yes

    TE Code : AB

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 3MG

    Approval Date : 2006-12-19

    Application Number : 21999

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 6MG

    Approval Date : 2006-12-19

    Application Number : 21999

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 9MG

    Approval Date : 2006-12-19

    Application Number : 21999

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2006-12-19

    Application Number : 21999

    RX/OTC/DISCN : DISCN

    RLD : Yes

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    RLD : Yes

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2008-08-26

    Application Number : 21999

    RX/OTC/DISCN : DISCN

    RLD : Yes

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    RLD :

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Dosage Strength : 3MG

    Approval Date :

    Application Number : 22043

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD :

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Dosage Strength : 6MG

    Approval Date :

    Application Number : 22043

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD :

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Dosage Strength : 9MG

    Approval Date :

    Application Number : 22043

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD :

    TE Code :

    PALIPERIDONE

    Brand Name : INVEGA

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Dosage Strength : 12MG

    Approval Date :

    Application Number : 22043

    RX/OTC/DISCN :

    RLD :

    TE Code :

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