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    Dexmedetomidine

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    01 1ACCORD HLTHCARE

    02 1ACTAVIS INC

    03 1AM REGENT

    04 2AMNEAL

    05 2AMNEAL PHARMS CO

    06 2BAXTER HLTHCARE CORP

    07 2BIOXCEL

    08 3ENDO OPERATIONS

    09 3EUGIA PHARMA

    10 5FRESENIUS KABI USA

    11 3GLAND

    12 4HENGRUI PHARMA

    13 3HIKMA

    14 5HOSPIRA

    15 4HQ SPCLT PHARMA

    16 1MEITHEAL

    17 2MILLA PHARMS

    18 1MYLAN INSTITUTIONAL

    19 2MYLAN LABS LTD

    20 1PIRAMAL CRITICAL

    21 1RISING

    22 1SANDOZ

    23 2SOMERSET

    24 3TAGI

    25 1TEVA PHARMS USA

    26 3WILSHIRE PHARMS INC

    27 1ZYDUS PHARMS

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    01

    FRESENIUS KABI USA

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    FRESENIUS KABI USA

    U.S.A
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    AACR Annual meeting
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    RLD : No

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 2015-09-18

    Application Number : 201072

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    02

    GLAND

    India
    AACR Annual meeting
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    GLAND

    India
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    RLD : No

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 2015-08-20

    Application Number : 202126

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    03

    HOSPIRA

    U.S.A
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    HOSPIRA

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    RLD : Yes

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : PRECEDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 1999-12-17

    Application Number : 21038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    04

    HOSPIRA

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    HOSPIRA

    U.S.A
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    RLD : Yes

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : PRECEDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

    Approval Date : 2013-03-13

    Application Number : 21038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    05

    HOSPIRA

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Not Confirmed
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    RLD : Yes

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : PRECEDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

    Approval Date : 2013-03-13

    Application Number : 21038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    06

    HOSPIRA

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    HOSPIRA

    U.S.A
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    RLD : Yes

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : PRECEDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

    Approval Date : 2014-11-14

    Application Number : 21038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    07

    HOSPIRA

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    HOSPIRA

    U.S.A
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    RLD : Yes

    TE Code :

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : PRECEDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

    Approval Date : 2020-01-31

    Application Number : 21038

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    RISING

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    RISING

    U.S.A
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    AACR Annual meeting
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    RLD : No

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 2014-11-24

    Application Number : 202585

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    09

    SANDOZ

    Switzerland
    AACR Annual meeting
    Not Confirmed
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    SANDOZ

    Switzerland
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    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 2016-06-14

    Application Number : 91465

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    10

    MYLAN INSTITUTIONAL

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    MYLAN INSTITUTIONAL

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code : AP

    DEXMEDETOMIDINE HYDROCHLORIDE

    Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

    Approval Date : 2014-08-18

    Application Number : 202881

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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