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    01 6ACTAVIS ELIZABETH

    02 1ACTAVIS LABS UT INC

    03 3ALKEM LABS LTD

    04 9COLLEGIUM PHARM INC

    05 2HUMANWELL PHARMACEUTICAL US INC

    06 2RHODES PHARMS

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    01

    ACTAVIS ELIZABETH

    Ireland
    India Med Expo
    Not Confirmed
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    ACTAVIS ELIZABETH

    Ireland
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    RLD :

    TE Code :

    TAPENTADOL

    Brand Name : TAPENTADOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date :

    Application Number : 204971

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    02

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
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    India Med Expo
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 50MG BASE

    Approval Date : 2008-11-20

    Application Number : 22304

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    03

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
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    India Med Expo
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 75MG BASE

    Approval Date : 2008-11-20

    Application Number : 22304

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    04

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
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    India Med Expo
    Not Confirmed
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 100MG BASE

    Approval Date : 2008-11-20

    Application Number : 22304

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    05

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
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    India Med Expo
    Not Confirmed
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA ER

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 50MG BASE

    Approval Date : 2011-08-25

    Application Number : 200533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    06

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
    arrow
    India Med Expo
    Not Confirmed
    • fda
    • EDQM
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA ER

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 100MG BASE

    Approval Date : 2011-08-25

    Application Number : 200533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    07

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
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    India Med Expo
    Not Confirmed
    • fda
    • EDQM
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA ER

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 150MG BASE

    Approval Date : 2011-08-25

    Application Number : 200533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    08

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
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    COLLEGIUM PHARM INC

    U.S.A
    arrow
    India Med Expo
    Not Confirmed
    • fda
    • EDQM
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA ER

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2011-08-25

    Application Number : 200533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

    Portfolio PDF

    Product Web Link

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    09

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
    arrow

    COLLEGIUM PHARM INC

    U.S.A
    arrow
    India Med Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA ER

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 250MG BASE

    Approval Date : 2011-08-25

    Application Number : 200533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    Product Web Link

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    Digital Content

    Website

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    10

    COLLEGIUM PHARM INC

    U.S.A
    India Med Expo
    Not Confirmed
    arrow

    COLLEGIUM PHARM INC

    U.S.A
    arrow
    India Med Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    TAPENTADOL HYDROCHLORIDE

    Brand Name : NUCYNTA

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2012-10-15

    Application Number : 203794

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    blank

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