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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 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 24306 | ZOLEDRONIC ACID MONOHYDRATE | 2010-10-13 | Active | II | Complete | 2016-06-03 | 2015-08-27 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 21344 | ZOLEDRONIC ACID MONOHYDRATE USP | 2008-02-18 | Active | II | N/A |