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01 2HONG KONG

02 2Nabriva Therapeutics

03 4Venipharm

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PharmaCompass

01

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin

Brand Name : Xenleta

Dosage Form : Infusion Solution

Dosage Strength : 150mg

Packaging :

Approval Date : 27-07-2020

Application Number : 28106272319

Regulatory Info : Prescription

Registration Country : Denmark

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02

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin

Brand Name : Xenleta

Dosage Form : Film Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 27-07-2020

Application Number : 28106272419

Regulatory Info : Prescription

Registration Country : Denmark

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03

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin

Brand Name : Xenleta

Dosage Form : Infusion Solution

Dosage Strength : 10mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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04

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin

Brand Name : Xenleta

Dosage Form : Film-Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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05

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin Acetate

Brand Name : Xenleta

Dosage Form : Infusion Solution

Dosage Strength : 150mg

Packaging :

Approval Date : 27-07-2020

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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06

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Lefamulin Acetate

Brand Name : Xenleta

Dosage Form : Film Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 27-07-2020

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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07

HONG KONG

Country
BioProcess International US West
Not Confirmed
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HONG KONG

Country
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BioProcess International US West
Not Confirmed

LEFAMULIN ACETATE

Brand Name : XENLETA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE

Packaging :

Approval Date : 2019-08-19

Application Number : 211672

Regulatory Info : RX

Registration Country : USA

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08

HONG KONG

Country
BioProcess International US West
Not Confirmed
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HONG KONG

Country
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BioProcess International US West
Not Confirmed

LEFAMULIN ACETATE

Brand Name : XENLETA

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 150MG BASE/15ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2019-08-19

Application Number : 211673

Regulatory Info : RX

Registration Country : USA

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