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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 Lupin Ltd
India
LUPIN LTD 31143 HYDROCORTISONE VALERATE USP 2016-12-30 Active II Complete 2017-03-02 2017-01-09
28/03/2025 Symbiotica Specialty Ingredients
Malaysia
SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD 31423 HYDROCORTISONE VALERATE USP 2017-02-01 Active II Complete 2017-11-07 2017-06-05