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    Dexmedetomidine Hydrochloride

    ACTIVE PHARMA INGREDIENTS

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    01 1ACCORD HLTHCARE

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    01

    FRESENIUS KABI USA

    U.S.A
    Antibody Engineering
    Not Confirmed
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    FRESENIUS KABI USA

    U.S.A
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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
    Antibody Engineering
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    GLAND

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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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    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
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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
    Antibody Engineering
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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 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
    Antibody Engineering
    Not Confirmed
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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 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
    Antibody Engineering
    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
    Antibody Engineering
    Not Confirmed
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    RISING

    U.S.A
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    Antibody Engineering
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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
    Antibody Engineering
    Not Confirmed
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    SANDOZ

    Switzerland
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    Antibody Engineering
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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
    Antibody Engineering
    Not Confirmed
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    MYLAN INSTITUTIONAL

    U.S.A
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    Antibody Engineering
    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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