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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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Defibrotide

Brand Name : Defitelio

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 80mg/ml

Packaging :

Approval Date : 18/10/2013

Application Number : 20110505000017

Regulatory Info : Approved

Registration Country : Sweden

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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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Patents & EXCLUSIVITIES

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JAZZ PHARMS INC

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DEFIBROTIDE SODIUM

US Patent Number : 11236328

Drug Substance Claim :

Drug Product Claim :

Application Number : 208114

Patent Use Code : U-3301

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-06-22

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JAZZ PHARMS INC

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DEFIBROTIDE SODIUM

US Patent Number : 11085043

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 208114

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-06-22

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JAZZ PHARMS INC

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DEFIBROTIDE SODIUM

US Patent Number : 11746348

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 208114

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-06-22

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