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List of Drug Master Files (DMF) of DSSTox_CID_3624 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 Aurore Life Sciences
India
AURORE LIFE SCIENCES PRIVATE LTD 36760 SULINDAC 2022-02-03 Active II N/A
26/09/2024 F.I.S. Fabbrica Italiana Sintetici
Italy
FIS FABBRICA ITALIANA SINTETICI SPA 6187 SULINDAC 1986-02-11 Active II Complete 2017-10-27 2017-10-04