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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 | 30555 | DAPAGLIFLOZIN | 2016-05-12 | Active | II | Complete | 2017-05-23 | 2016-12-08 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 30729 | DAPAGLIFLOZIN (AMORPHOUS) | 2016-12-30 | Active | II | Complete | 2017-04-17 | 2017-03-20 |