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    IMIPENEM; CILASTATIN

    ACTIVE PHARMA INGREDIENTS

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    01 2ACS DOBFAR SPA

    02 1Antibiotice SA

    03 1HQ SPCLT PHARMA

    04 3Hospira, Inc.

    05 1JW Pharmaceutical Corporation

    06 1MSD INTL GMBH

    07 6Merck & Co

    08 1Myungmoon Pharm. Co., LTD.

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    01

    ACS DOBFAR SPA

    Italy
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    ACS DOBFAR SPA

    Italy
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    Regulatory Info : RX

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 250MG BASE/VIAL;250MG/VIAL

    Packaging :

    Approval Date : 2011-12-21

    Application Number : 90577

    Regulatory Info : RX

    Registration Country : USA

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    02

    ACS DOBFAR SPA

    Italy
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    ACS DOBFAR SPA

    Italy
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    Regulatory Info : RX

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 2011-12-21

    Application Number : 90577

    Regulatory Info : RX

    Registration Country : USA

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    03

    Antibiotice SA

    Romania
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    Antibiotice SA

    Romania
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    Regulatory Info :

    Registration Country : Romania

    Imipenem; Cilastatin Sodium

    Brand Name : IMIPENEM/CILASTATIN Atb®

    Dosage Form : powder for injection/Infusion

    Dosage Strength : 500MG; 500MG

    Packaging : Box x 1 vials, Box x 5 vials, Box x 10 vials

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    Registration Country : Romania

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    04

    Hospira, Inc.

    U.S.A
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    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 250MG BASE/VIAL;250MG/VIAL

    Packaging :

    Approval Date : 2011-11-16

    Application Number : 90825

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Hospira, Inc.

    U.S.A
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    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 2011-11-16

    Application Number : 90825

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Hospira, Inc.

    U.S.A
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    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 2011-11-16

    Application Number : 91007

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    HQ SPCLT PHARMA

    U.S.A
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    HQ SPCLT PHARMA

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : IMIPENEM AND CILASTATIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 2019-12-12

    Application Number : 207594

    Regulatory Info : RX

    Registration Country : USA

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    08

    JW Pharmaceutical Corporation

    South Korea
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    JW Pharmaceutical Corporation

    South Korea
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    Regulatory Info : Generic

    Registration Country : South Korea

    Cilastatin Sodium

    Brand Name : Prepenem

    Dosage Form : Injection

    Dosage Strength : 500|500MG

    Packaging : 500mg × 10 Vials

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Korea

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    09

    Merck & Co

    U.S.A
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    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1985-11-26

    Application Number : 50587

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Merck & Co

    U.S.A
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    Merck & Co

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 1985-11-26

    Application Number : 50587

    Regulatory Info : RX

    Registration Country : USA

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    11

    Merck & Co

    U.S.A
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    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : POWDER;INTRAMUSCULAR

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 1990-12-14

    Application Number : 50630

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Merck & Co

    U.S.A
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    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : POWDER;INTRAMUSCULAR

    Dosage Strength : EQ 750MG BASE/VIAL;750MG/VIAL

    Packaging :

    Approval Date : 1990-12-14

    Application Number : 50630

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Merck & Co

    U.S.A
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    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 250MG BASE/VIAL;250MG/VIAL

    Packaging :

    Approval Date : 1987-01-08

    Application Number : 62756

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Merck & Co

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM

    Brand Name : PRIMAXIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL

    Packaging :

    Approval Date : 1987-01-08

    Application Number : 62756

    Regulatory Info : DISCN

    Registration Country : USA

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    15

    MSD INTL GMBH

    Singapore
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    MSD INTL GMBH

    Singapore
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    Regulatory Info : RX

    Registration Country : USA

    CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

    Brand Name : RECARBRIO

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL

    Packaging :

    Approval Date : 2019-07-16

    Application Number : 212819

    Regulatory Info : RX

    Registration Country : USA

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    16

    Myungmoon Pharm. Co., LTD.

    South Korea
    PackExpo
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    Myungmoon Pharm. Co., LTD.

    South Korea
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    Regulatory Info : Generic

    Registration Country : South Korea

    Imipenem; Cilastatin Sodium

    Brand Name : Tipem

    Dosage Form : INJECTION

    Dosage Strength : 530MG; 532MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Korea

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