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01 2ACS DOBFAR SPA

02 1Antibiotice

03 1Campus Pharma AB

04 2ELC Group

05 3Fresenius Kabi AB Brunna

06 1HQ SPCLT PHARMA

07 3Hospira, Inc.

08 1JW Pharmaceutical Corporation

09 1Karo Pharma

10 1MSD INTL GMBH

11 1Medartuum

12 1Medreg

13 8Merck & Co

14 1Myungmoon Pharm. Co., LTD.

15 1ORIFARM GROUP AS

16 1Pfizer Inc

17 1RANBAXY LABORATORIES LIMITED

18 2Sandoz B2B

19 1Steriscience

20 1Stravencon

21 1Teva Pharmaceutical Industries

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Romania

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Fresenius Kabi

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 09/10/2009

Application Number : 20071211000015

Regulatory Info : Approved

Registration Country : Sweden

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Tienam

Dosage Form : Solution For Injection

Dosage Strength :

Packaging :

Approval Date : 02/11/2001

Application Number : 20011102000052

Regulatory Info : Deregistered

Registration Country : Sweden

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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16

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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17

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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18

FNCE
Not Confirmed
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FNCE
Not Confirmed

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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19

FNCE
Not Confirmed
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FNCE
Not Confirmed

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Orifarm

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 12/03/2024

Application Number : 20231109000071

Regulatory Info : Approved

Registration Country : Sweden

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20

FNCE
Not Confirmed
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FNCE
Not Confirmed

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Steriscience

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 14/12/2023

Application Number : 20211206000037

Regulatory Info : Approved

Registration Country : Sweden

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