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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 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 26475 DUTASTERIDE (PROCESS-II) USP 2012-10-03 Active II Complete 2013-08-12 2012-11-30
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 29577 DUTASTERIDE USP 2015-07-31 Active II Complete 2015-12-04 2015-07-28