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    Azelastine hydrochloride, United States Pharmacopeia (USP) Reference Standard

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    01 1AbbVie Inc

    02 2Octavius Pharma Pvt. Ltd

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    01

    AbbVie Inc

    U.S.A
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    Regulatory Info : Authorised

    Registration Country : Malta

    Azelastine Hydrochloride

    Brand Name : Antalerg

    Dosage Form : Eye Drop Solution

    Dosage Strength : 0.5MG/ML

    Packaging :

    Approval Date : 2024-08-29

    Application Number :

    Regulatory Info : Authorised

    Registration Country : Malta

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    02

    Octavius Pharma Pvt. Ltd

    India
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    Registration Country : India

    Azelastine Hydrochloride

    Brand Name : Azelastine Hydrochloride

    Dosage Form : Nasal Spray

    Dosage Strength : 0.1%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    03

    Octavius Pharma Pvt. Ltd

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

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    Registration Country : India

    Azelastine Hydrochloride; Fluticasone Propionate

    Brand Name : Azelastine Hydrochloride; Fluticasone Propionate

    Dosage Form : Nasal Spray

    Dosage Strength : 140MCG; 27.5MCG

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    04

    Apotex Inc

    Canada
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    Canada
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    Regulatory Info : RX

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2009-04-30

    Application Number : 77954

    Regulatory Info : RX

    Registration Country : USA

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    05

    Apotex Inc

    Canada
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    Regulatory Info : RX

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 0.05%

    Packaging :

    Approval Date : 2009-08-03

    Application Number : 78621

    Regulatory Info : RX

    Registration Country : USA

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    06

    Apotex Inc

    Canada
    IPPE
    Not Confirmed
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    Apotex Inc

    Canada
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.2055MG/SPRAY

    Packaging :

    Approval Date : 2012-08-31

    Application Number : 201846

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Bionpharma

    U.S.A
    IPPE
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    Bionpharma

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2015-07-28

    Application Number : 90176

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Hikma Pharmaceuticals

    United Kingdom
    IPPE
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    Hikma Pharmaceuticals

    United Kingdom
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2014-10-24

    Application Number : 91444

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Meda Pharmaceuticals Inc.

    U.S.A
    IPPE
    Not Confirmed
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    Meda Pharmaceuticals Inc.

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    Regulatory Info :

    Registration Country : USA

    AZELASTINE HYDROCHRLORIDE

    Brand Name : ASTEPRO

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.1%

    Packaging :

    Approval Date :

    Application Number : 22371

    Regulatory Info :

    Registration Country : USA

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    10

    Meda Pharmaceuticals Inc.

    U.S.A
    IPPE
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    Meda Pharmaceuticals Inc.

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    AZELASTINE HYDROCHRLORIDE

    Brand Name : ASTEPRO

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.15%

    Packaging :

    Approval Date :

    Application Number : 22371

    Regulatory Info :

    Registration Country : USA

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    11

    Padagis

    Israel
    IPPE
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    Padagis

    Israel
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2017-03-17

    Application Number : 202609

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Rising Pharmaceuticals Inc

    U.S.A
    IPPE
    Not Confirmed
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    Rising Pharmaceuticals Inc

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : ASTELIN

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1996-11-01

    Application Number : 20114

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Rising Pharmaceuticals Inc

    U.S.A
    IPPE
    Not Confirmed
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    Rising Pharmaceuticals Inc

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : OPTIVAR

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 2000-05-22

    Application Number : 21127

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Sandoz B2B

    Switzerland
    IPPE
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    Sandoz B2B

    Switzerland
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    Regulatory Info : RX

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 0.05%

    Packaging :

    Approval Date : 2012-05-31

    Application Number : 202305

    Regulatory Info : RX

    Registration Country : USA

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    15

    Sun Pharmaceutical Industries Limit...

    India
    IPPE
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    India
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    Regulatory Info : DISCN

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    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 0.05%

    Packaging :

    Approval Date : 2010-06-21

    Application Number : 78738

    Regulatory Info : DISCN

    Registration Country : USA

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    16

    Sun Pharmaceutical Industries Limit...

    India
    IPPE
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    Sun Pharmaceutical Industries Limit...

    India
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    Regulatory Info : DISCN

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    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2012-05-23

    Application Number : 90423

    Regulatory Info : DISCN

    Registration Country : USA

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    17

    Viatris

    U.S.A
    IPPE
    Not Confirmed
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    Viatris

    U.S.A
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    AZELASTINE HYDROCHLORIDE

    Brand Name : ASTEPRO

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 2008-10-15

    Application Number : 22203

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Viatris

    U.S.A
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    Regulatory Info : DISCN

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    AZELASTINE HYDROCHLORIDE

    Brand Name : ASTEPRO

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.2055MG/SPRAY

    Packaging :

    Approval Date : 2009-08-31

    Application Number : 22203

    Regulatory Info : DISCN

    Registration Country : USA

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    19

    Viatris

    U.S.A
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    Viatris

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    Regulatory Info : RX

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    AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

    Brand Name : DYMISTA

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY;0.05MG/SPRAY

    Packaging :

    Approval Date : 2012-05-01

    Application Number : 202236

    Regulatory Info : RX

    Registration Country : USA

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    20

    Zydus Pharmaceuticals

    U.S.A
    IPPE
    Not Confirmed
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    U.S.A
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    Regulatory Info : RX

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    AZELASTINE HYDROCHLORIDE

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Form : SPRAY, METERED;NASAL

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2017-08-14

    Application Number : 91409

    Regulatory Info : RX

    Registration Country : USA

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.