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01 3AbbVie Inc

02 1ANFARM HELLAS S.A.

03 2Accord healthcare

04 1Adalvo

05 1Bayer AG

06 1BioARS Therapeutics S.A.

07 1Bioglan

08 1DURATA THERAPS INTL

09 1ELPEN Pharmaceutical

10 2Galenicum

11 1Reig Jofre

12 1Teva Pharmaceutical Industries

13 2Zentiva

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PharmaCompass

01

DALBAVANCIN HYDROCHLORIDE

Brand Name : DALVANCE

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 500MG BASE/VIAL

Packaging :

Approval Date : 2014-05-23

Application Number : 21883

Regulatory Info : RX

Registration Country : USA

Abbvie Company Banner

02

Dalbavancin

Brand Name : Xydalba

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 19/02/2015

Application Number : 20131130000029

Regulatory Info : Approved

Registration Country : Sweden

Abbvie Company Banner

03

Dalbavancina

Brand Name : Xydalba

Dosage Form : Powder For Concentrate And Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2015-06-27

Application Number : 114986001

Regulatory Info : Authorized

Registration Country : Spain

Abbvie Company Banner

04

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Accord

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 11/06/2024

Application Number : 20230223000066

Regulatory Info : Approved

Registration Country : Sweden

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancina

Brand Name : Dalbavancina Accord

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-05-17

Application Number : 89574

Regulatory Info : Authorized

Registration Country : Spain

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin

Brand Name : Deirate

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-06-21

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin

Brand Name : Dalbavancin Anfarm

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-06-12

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Baxter

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230227000031

Regulatory Info : Approved

Registration Country : Sweden

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Bioglan

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 26/04/2024

Application Number : 20230223000011

Regulatory Info : Approved

Registration Country : Sweden

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Zeven

Brand Name : Xydalba

Dosage Form : Dalbavancina 500Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle groun EV 500 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Bavalda

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-07-03

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Adair

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-07-03

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Diagonalis

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-07-03

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancina

Brand Name : Dalbavancina Sala

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-05-07

Application Number : 89545

Regulatory Info : Authorized

Registration Country : Spain

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Teva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230901000074

Regulatory Info : Approved

Registration Country : Sweden

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16

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Zentiva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 21/07/2025

Application Number : 20230801000099

Regulatory Info : Approved

Registration Country : Sweden

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17

AAPS
Not Confirmed
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Zentiva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-07-03

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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18

BioARS Therapeutics S.A.

Country
AAPS
Not Confirmed
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BioARS Therapeutics S.A.

Country
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AAPS
Not Confirmed

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Bioars

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2025-07-03

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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