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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
25/04/2025 Ajinomoto Company
Japan
NV AJINOMOTO OMNICHEM SA 27904 MICONAZOLE NITRATE 2014-02-19 Active II Complete 2015-03-16 2014-02-14
25/04/2025 Catalent Pharma Solutions
U.S.A
CATALENT PHARMA SOLUTIONS LLC 12938 MICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE 1998-04-08 Inactive II N/A