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01 11Sanofi

02 1Orion Corporation

03 1Actavis Inc

04 1Alkem Laboratories

05 1Amneal Pharmaceuticals

06 3Aristo Pharma GmbH

07 1Ascent Innovative Medicines

08 2Aurobindo Pharma Limited

09 2Aurovitas Spain, Sau

10 1Farm Agon

11 1Glenmark Pharmaceuticals

12 1Globela Pharma

13 1Lupin Ltd

14 1Ratiopharm Espana Sa

15 1STADA Arzneimittel

16 3Sandoz B2B

17 2Teva Pharmaceutical Industries

18 1Unichem Laboratories Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : RX

Registration Country : USA

DRONEDARONE HYDROCHLORIDE

Brand Name : MULTAQ

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Packaging :

Approval Date : 2009-07-01

Application Number : 22425

Regulatory Info : RX

Registration Country : USA

Sanofi Company Banner

02

Dronedarone Hydrochloride

Brand Name : Dronedaron Orion

Dosage Form : Film Coated Tablet

Dosage Strength : 400mg

Packaging :

Approval Date : 13/06/2022

Application Number : 20201215000012

Regulatory Info : Deregistered

Registration Country : Sweden

Fermion Orion Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Italy

Dronedarone

Brand Name : Multaq

Dosage Form : Dronedarone 400Mg 60 Units Oral Use

Dosage Strength : 60 cpr riv 400 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Norway

Dronedarone

Brand Name : Multaq

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 400 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Norway

Dronedarone

Brand Name : Multaq

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 400 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info :

Registration Country : Italy

Dronedarone

Brand Name : MULTIQ

Dosage Form : Film-Coated Tablet - Oral Use

Dosage Strength : 400 mg

Packaging : 60 UNITS 400 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Allowed

Registration Country : Switzerland

Dronedarone

Brand Name : Multaq

Dosage Form : Film Coated Tablet

Dosage Strength : 400mg

Packaging :

Approval Date : 16/09/2009

Application Number : 59292

Regulatory Info : Allowed

Registration Country : Switzerland

Sanofi Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Approved

Registration Country : Sweden

Dronedarone Hydrochloride

Brand Name : Multaq

Dosage Form : Film Coated Tablet

Dosage Strength : 400mg

Packaging :

Approval Date : 26/11/2009

Application Number : 20080730000017

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Prescription

Registration Country : Canada

DRONEDARONE (DRONEDARONE HYDROCHLORIDE)

Brand Name : MULTAQ

Dosage Form : TABLET

Dosage Strength : 400MG

Packaging : 60/180

Approval Date :

Application Number : 2330989

Regulatory Info : Prescription

Registration Country : Canada

Sanofi Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Authorized

Registration Country : Spain

Dronedarone

Brand Name : Multaq

Dosage Form : Film Coated Tablet

Dosage Strength : 400MG

Packaging :

Approval Date : 2024-11-26

Application Number : 09591003IP

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Authorized

Registration Country : Spain

Dronedarone

Brand Name : Multaq

Dosage Form : Film Coated Tablet

Dosage Strength : 400MG

Packaging :

Approval Date : 2025-02-27

Application Number : 09591003IP1

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

12

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Authorized

Registration Country : Spain

Dronedarone

Brand Name : Multaq

Dosage Form : Film Coated Tablet

Dosage Strength : 400MG

Packaging :

Approval Date : 2009-12-15

Application Number : 09591003

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

13

PREP
Not Confirmed
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PREP
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DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 205682

Regulatory Info :

Registration Country : USA

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14

PREP
Not Confirmed
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PREP
Not Confirmed

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 205895

Regulatory Info :

Registration Country : USA

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15

PREP
Not Confirmed
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PREP
Not Confirmed

DRONEDARONE

Brand Name : DRONEDARONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 206649

Regulatory Info :

Registration Country : USA

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16

PREP
Not Confirmed
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PREP
Not Confirmed

DRONEDARONE

Brand Name : DRONEDARONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 210678

Regulatory Info :

Registration Country : USA

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17

PREP
Not Confirmed
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PREP
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DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 205903

Regulatory Info :

Registration Country : USA

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18

PREP
Not Confirmed
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PREP
Not Confirmed

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Packaging :

Approval Date : 2024-01-31

Application Number : 205904

Regulatory Info : RX

Registration Country : USA

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19

PREP
Not Confirmed
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PREP
Not Confirmed

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number : 205744

Regulatory Info :

Registration Country : USA

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20

PREP
Not Confirmed
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PREP
Not Confirmed

Dronedarone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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