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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 | 33387 | DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE | 2018-12-30 | Active | II | Complete | 2019-07-16 | 2018-12-20 |
28/10/2024 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 33026 | DAPAGLIFLOZIN PROPANEDIOL | 2018-08-14 | Active | II | N/A |
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