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    Dexmedetomidine

    ACTIVE PHARMA INGREDIENTS

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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 1GLAND

    12 2GLAND PHARMA LTD

    13 4HENGRUI PHARMA

    14 3HIKMA

    15 5HOSPIRA

    16 4HQ SPCLT PHARMA

    17 1MEITHEAL

    18 2MILLA PHARMS

    19 1MYLAN INSTITUTIONAL

    20 2MYLAN LABS LTD

    21 1PIRAMAL CRITICAL

    22 1RISING

    23 1SANDOZ

    24 2SOMERSET

    25 3TAGI

    26 1TEVA PHARMS USA

    27 3WILSHIRE PHARMS INC

    28 1ZYDUS PHARMS

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    01

    FRESENIUS KABI USA

    U.S.A
    Plastics Recycling EU
    Not Confirmed
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    FRESENIUS KABI USA

    U.S.A
    arrow
    Plastics Recycling EU
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    Plastics Recycling EU
    Not Confirmed
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    GLAND

    India
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    Plastics Recycling EU
    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 : 2015-08-20

    Application Number : 202126

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    03

    HOSPIRA

    U.S.A
    Plastics Recycling EU
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Plastics Recycling EU
    Not Confirmed
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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
    Plastics Recycling EU
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Plastics Recycling EU
    Not Confirmed
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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
    Plastics Recycling EU
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Plastics Recycling EU
    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
    Plastics Recycling EU
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Plastics Recycling EU
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    Plastics Recycling EU
    Not Confirmed
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    HOSPIRA

    U.S.A
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    Plastics Recycling EU
    Not Confirmed
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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
    Plastics Recycling EU
    Not Confirmed
    arrow

    RISING

    U.S.A
    arrow
    Plastics Recycling EU
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    Plastics Recycling EU
    Not Confirmed
    arrow

    SANDOZ

    Switzerland
    arrow
    Plastics Recycling EU
    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
    Plastics Recycling EU
    Not Confirmed
    arrow

    MYLAN INSTITUTIONAL

    U.S.A
    arrow
    Plastics Recycling EU
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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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