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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
28/03/2025 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 30747 HYDROXYPROGESTERONE CAPROATE USP 2016-07-19 Active II Complete 2017-06-16 2017-01-30
28/03/2025 Aspen API
Netherlands
ASPEN OSS BV 17113 HYDROXYPROGESTERONE CAPROATE 2004-01-21 Active II Complete 2017-02-01 2017-01-09