Dasabuvir Sodium | All | Licensing, EU CTD Dossiers, Formulation Suppliers

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U.S.A

Regulatory Info : DISCN

Registration Country : USA

DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR

Brand Name : VIEKIRA PAK (COPACKAGED)

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 250MG BASE;12.5MG, 75MG, 50MG

Packaging :

Approval Date : 2014-12-19

Application Number : 206619

Regulatory Info : DISCN

Registration Country : USA

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02

AbbVie Inc

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U.S.A

Regulatory Info : DISCN

Registration Country : USA

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Brand Name : VIEKIRA XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2016-07-22

Application Number : 208624

Regulatory Info : DISCN

Registration Country : USA

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03

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : U.S.A

Dasabuvir Sodium

Brand Name : Exviera

Dosage Form : Dasabuvir 250Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 250 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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04

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : U.S.A

Dasabuvir Sodium

Brand Name : Exviera

Dosage Form : Film Tablet

Dosage Strength : Exviera, Filmtabl 250 mg, 56 Stk

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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05

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : U.S.A

Dasabuvir Sodium

Brand Name : Exviera

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 250 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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06

AbbVie Inc

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U.S.A

Regulatory Info : Deregistered

Registration Country : Sweden

Dasabuvirnatrium

Brand Name : Exviera

Dosage Form : Film Coated Tablet

Dosage Strength : 250mg

Packaging :

Approval Date : 15/01/2015

Application Number : 20140508000097

Regulatory Info : Deregistered

Registration Country : Sweden

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07

AbbVie Inc

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U.S.A

Regulatory Info : Cancelled

Registration Country : Spain

Dasabuvir

Brand Name : Exviera

Dosage Form : Film Coated Tablet

Dosage Strength : 250MG

Packaging :

Approval Date : 2015-02-03

Application Number : 114983001

Regulatory Info : Cancelled

Registration Country : Spain

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