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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 Aspen API
Netherlands
ASPEN OSS BV 10457 MIRTAZAPINE 1993-08-30 Active II N/A
25/04/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 16007 MIRTAZAPINE 2002-06-11 Active II N/A