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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 Pfizer CentreOne
U.S.A
PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC 5498 HYDROCORTISONE ACETATE USP, MICRO & NON-MICRO 1984-06-11 Active II Complete 2013-10-18 2013-02-14
25/04/2025 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 30820 HYDROCORTISONE ACETATE USP 2016-08-05 Active II Complete 2016-12-15 2016-10-27