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    Aspen API

    Netherlands
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    Regulatory Info : Authorized

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    Atracurium Besylate

    Brand Name : Tracrium

    Dosage Form : Injectable And Infusion Solution

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 01-09-1987

    Application Number : 57335

    Regulatory Info : Authorized

    Registration Country : Spain

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    02

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Atracurium Besilate

    Brand Name : Tracrium

    Dosage Form : Solution For Injection And Infusion

    Dosage Strength : 10MG/ML

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    Approval Date : 2005-11-25

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    Regulatory Info : Withdrawn

    Registration Country : Malta

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    03

    Aspen Pharmacare Holdings

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    Regulatory Info : Originator

    Registration Country : South Africa

    Atracurium

    Brand Name : Tracrium Injection 5ml

    Dosage Form : INJ

    Dosage Strength : 50mg/5ml

    Packaging : 5X5mg/5ml

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    Registration Country : South Africa

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    Atracurium

    Brand Name : Tracrium Injection 2,5 Ml

    Dosage Form : INJ

    Dosage Strength : 25mg/2.5ml

    Packaging : 2.5X5mg/2.5ml

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    Registration Country : South Africa

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    05

    Actavis Inc

    Ireland
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1998-07-28

    Application Number : 74944

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    Registration Country : USA

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    Actavis Inc

    Ireland
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1998-07-28

    Application Number : 74945

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    07

    Baxter Healthcare Corporation

    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

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    Approval Date : 1997-01-23

    Application Number : 74753

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    Registration Country : USA

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    Baxter Healthcare Corporation

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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-01-23

    Application Number : 74768

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    Registration Country : USA

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    09

    Baxter Healthcare Corporation

    U.S.A
    euroPLX 90 Lisbon
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-09-30

    Application Number : 74824

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    Registration Country : USA

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    10

    Baxter Healthcare Corporation

    U.S.A
    euroPLX 90 Lisbon
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    Regulatory Info : DISCN

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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-09-30

    Application Number : 74825

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    Registration Country : USA

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    11

    Hikma Pharmaceuticals

    United Kingdom
    euroPLX 90 Lisbon
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    United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-07-18

    Application Number : 74900

    Regulatory Info : RX

    Registration Country : USA

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    12

    Hikma Pharmaceuticals

    United Kingdom
    euroPLX 90 Lisbon
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    United Kingdom
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    Regulatory Info : RX

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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-07-18

    Application Number : 74901

    Regulatory Info : RX

    Registration Country : USA

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    13

    Hospira, Inc.

    U.S.A
    euroPLX 90 Lisbon
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    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : TRACRIUM PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 1983-11-23

    Application Number : 18831

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Hospira, Inc.

    U.S.A
    euroPLX 90 Lisbon
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    ATRACURIUM BESYLATE

    Brand Name : TRACRIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    Approval Date : 1985-06-20

    Application Number : 18831

    Regulatory Info : DISCN

    Registration Country : USA

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    Hospira, Inc.

    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1996-12-23

    Application Number : 74632

    Regulatory Info : DISCN

    Registration Country : USA

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    Hospira, Inc.

    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1996-12-23

    Application Number : 74633

    Regulatory Info : DISCN

    Registration Country : USA

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    Hospira, Inc.

    U.S.A
    euroPLX 90 Lisbon
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    Hospira, Inc.

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    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

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    Approval Date : 1997-03-25

    Application Number : 74639

    Regulatory Info : DISCN

    Registration Country : USA

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    Hospira, Inc.

    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date : 1997-03-28

    Application Number : 74740

    Regulatory Info : DISCN

    Registration Country : USA

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    Hospira, Inc.

    U.S.A
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE PRESERVATIVE FREE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date : 1997-03-28

    Application Number : 74741

    Regulatory Info : DISCN

    Registration Country : USA

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    20

    Teva Pharmaceutical Industries

    Israel
    euroPLX 90 Lisbon
    Not Confirmed
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    Israel
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    ATRACURIUM BESYLATE

    Brand Name : ATRACURIUM BESYLATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10MG/ML

    Packaging :

    Approval Date : 1997-06-11

    Application Number : 74784

    Regulatory Info : DISCN

    Registration Country : USA

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