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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 30555 DAPAGLIFLOZIN 2016-05-12 Active II Complete 2017-05-23 2016-12-08
28/10/2024 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 30729 DAPAGLIFLOZIN (AMORPHOUS) 2016-12-30 Active II Complete 2017-04-17 2017-03-20