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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
27/09/2025 Merck Serono
Germany
EMD SERONO INC 11498 MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14 1995-05-08 Active II N/A
27/09/2025 SIMS Srl
Italy
SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL 5147 TETRAHYDROZOLINE HCl 1983-10-28 Active II N/A