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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
28/10/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 24306 ZOLEDRONIC ACID MONOHYDRATE 2010-10-13 Active II Complete 2016-06-03 2015-08-27
28/10/2024 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 21344 ZOLEDRONIC ACID MONOHYDRATE USP 2008-02-18 Active II N/A