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List of Drug Master Files (DMF) of Loratadine-d4 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 333Xls 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 Cadila Pharmaceuticals
India
CADILA PHARMACEUTICALS LTD 17582 LORATADINE USP POWDER 2004-07-10 Active II Complete 2013-09-21 2013-09-11
26/09/2024 Glenmark Life Sciences
India
GLENMARK LIFE SCIENCES LTD 19400 LORATADINE USP 2006-05-02 Active II N/A