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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
216119 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2022-08-01 JIANGSU HANSOH PHARM
211583 ANDA DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2022-08-03 TEVA PHARMS USA INC
211582 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2022-02-22 ZYDUS PHARMS
211564 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2020-03-20 GLENMARK GENERICS
211541 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2019-02-04 TEVA PHARMS USA INC
211533 ANDA DAPAGLIFLOZIN AND SAXAGLIPTIN DAPAGLIFLOZIN; SAXAGLIPTIN TABLET; ORAL 2020-05-28 MSN LABS PVT LTD
211532 ANDA DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE TABLET; ORAL LUPIN LTD
211523 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET; ORAL 2023-03-03 AIZANT
211478 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2021-02-26 MSN LABORATORIES PRIVATE LTD
211442 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2019-01-04 APOTEX INC
211439 ANDA DAPAGLIFLOZIN DAPAGLIFLOZIN TABLET;ORAL 2019-01-18 HETERO LABS UNIT III
210874 NDA QTERNMET XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2019-05-02 ASTRAZENECA AB
209091 NDA QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL 2017-02-27 ASTRAZENECA AB
205649 NDA XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2014-10-29 ASTRAZENECA AB
202293 NDA FARXIGA DAPAGLIFLOZIN TABLET;ORAL 2014-01-08 ASTRAZENECA AB