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Manufacturers & Suppliers of Viatris brand of azelastine hydrochloride Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 2Octavius Pharma Pvt. Ltd

02 2Hanlim Pharmaceutical

03 1Indiana Ophthalmics

04 1Indoco Remedies Limited

05 1Jiangsu Hengrui Medicine Co., Ltd.

06 1Kolmar Korea Co., Ltd.

07 2Laboratorios Salvat

08 2World Medicine

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Azelastine Hydrochloride

Brand Name :

Dosage Form : Nasal Spray

Dosage Strength : 0.1%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Packaging :

Regulatory Info :

Azelastine Hydrochloride

Dosage : Nasal Spray

Dosage Strength : 0.1%

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Azelastine Hydrochloride; Fluticasone Propionate

Brand Name :

Dosage Form : Nasal Spray

Dosage Strength : 140MCG; 27.5MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Packaging :

Regulatory Info :

Azelastine Hydrochloride; Fluticasone Propionate

Dosage : Nasal Spray

Dosage Strength : 140MCG; 27.5MCG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

03

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Mometasone Furoate; azelastine hydrochloride

Brand Name : NASAFLEX

Dosage Form : NASAL SPRAY

Dosage Strength : 0.5MG; 1.4MG

Packaging : 18g, 1btl

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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03

FNCE 2024
Not Confirmed
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04

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

azelastine hydrochloride

Brand Name : AZECLE

Dosage Form : EYE DROP

Dosage Strength : 0.5MG

Packaging : 5mL

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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05

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine

Brand Name :

Dosage Form : Eye Drops

Dosage Strength : 0.05%/W/V

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine

Dosage : Eye Drops

Dosage Strength : 0.05%/W/V

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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06

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

azelastine hydrochloride

Brand Name :

Dosage Form : Solution

Dosage Strength : 0.5MG/ML

Packaging : 5ml, 10 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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06

FNCE 2024
Not Confirmed
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07

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

azelastine hydrochloride

Brand Name :

Dosage Form : Nasal Spray

Dosage Strength : 10MG/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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08

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

azelastine hydrochloride

Brand Name : K-Stin Tablet

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

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09

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine Hydrochloride

Brand Name : Tebarat

Dosage Form : Solution

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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10

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine Hydrochloride

Brand Name : Tebarat Nasal

Dosage Form : Solution

Dosage Strength : 1MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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10

FNCE 2024
Not Confirmed
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11

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine Hydrochloride

Brand Name : AZZARA-NS

Dosage Form : NASAL SPRAY

Dosage Strength : 0.14MG/Dose

Packaging : 10 ML/BOTTLE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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11

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Azelastine Hydrochloride

Dosage : NASAL SPRAY

Dosage Strength : 0.14MG/Dose

Brand Name : AZZARA-NS

Approval Date :

Application Number :

Registration Country : Turkey

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12

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Fluticasone Propionate; Azelastine Hydrochloride

Brand Name : FLUTEL PLUS

Dosage Form : NASAL SPRAY

Dosage Strength : 50MCG; 120MCG

Packaging : 120 DOSE/TUBE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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12

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

Fluticasone Propionate; Azelastine Hydrochloride

Dosage : NASAL SPRAY

Dosage Strength : 50MCG; 120MCG

Brand Name : FLUTEL PLUS

Approval Date :

Application Number :

Registration Country : Turkey

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