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    List of Drug Master Files (DMF) of Azelastine Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Azelastine Hydrochloride

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    REF. STANDARDS & IMPURITIES

    PharmaCompass
    $ API Ref.Price (USD/KG) : 8,534Xls download

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 Coral Drugs Private Limited
    India
    		 CORAL DRUGS PRIVATE LTD 36205 AZELASTINE HYDROCHLORIDE USP 2021-10-09 Active II Complete 2023-11-01 2023-09-22
    26/09/2024 Evonik
    Germany
    		 EVONIK OPERATIONS GMBH 15440 AZELASTINE HYDROCHLORIDE 2001-05-15 Active II N/A