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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 33387 DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE 2018-12-30 Active II Complete 2019-07-16 2018-12-20
28/03/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 33026 DAPAGLIFLOZIN PROPANEDIOL 2018-08-14 Active II N/A