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

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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 EUROAPI
France
AVENTIS PHARMA MANUFACTURING PTE LTD 15890 SODIUM CROMOGLICATE 2002-03-08 Active II Complete 2013-03-07 2013-02-25
26/09/2024 Fermion Oy
Finland
FERMION OY 10006 CROMOLYN SODIUM 1992-12-15 Active II Complete 2018-06-13 2018-02-08