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01 1Tmc Pharma (Eu) Limited

02 1Zydus Lifesciences

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FNCE
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FOSDENOPTERIN HYDROBROMIDE

Brand Name : NULIBRY

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 9.5MG BASE/VIAL

Packaging :

Approval Date : 2021-02-26

Application Number : 214018

Regulatory Info : RX

Registration Country : USA

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Tmc Pharma (Eu) Limited

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FNCE
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Tmc Pharma (Eu) Limited

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FNCE
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Phosdenopterin Hydrobromide Dihydrate

Brand Name : Nulibry

Dosage Form : Powder For Solution For Injection

Dosage Strength : 9.5mg

Packaging :

Approval Date : 15/09/2022

Application Number : 20211105000015

Regulatory Info : Approved

Registration Country : Sweden

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