Find Defibrotide Sodium manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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FDF Dossiers

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01

BioProcess International US West
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BioProcess International US West
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DEFIBROTIDE SODIUM

Brand Name : DEFITELIO

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 200MG/2.5ML (80MG/ML)

Packaging :

Approval Date : 2016-03-30

Application Number : 208114

Regulatory Info : RX

Registration Country : USA

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02

BioProcess International US West
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BioProcess International US West
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Defibrotide

Brand Name : Defitelio

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 80mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

BioProcess International US West
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BioProcess International US West
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Defibrotide

Brand Name : Defitelio

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 80mg/ml

Packaging :

Approval Date : 18-10-2013

Application Number : 28104921111

Regulatory Info : Prescription

Registration Country : Denmark

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04

BioProcess International US West
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BioProcess International US West
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Defibrotide

Brand Name : Defitelio

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 80mg/ml

Packaging :

Approval Date : 18-10-2013

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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05

BioProcess International US West
Not Confirmed
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BioProcess International US West
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DEFIBROTIDE

Brand Name : DEFITELIO

Dosage Form : SOLUTION

Dosage Strength : 80MG/ML

Packaging : 2.5ML

Approval Date :

Application Number : 2465981

Regulatory Info : Schedule D

Registration Country : Canada

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