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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
213072 NDA ROSZET EZETIMIBE; ROSUVASTATIN CALCIUM TABLET;ORAL 2021-03-23 ALTHERA PHARMS
212059 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2019-11-04 ZHEJIANG YONGTAI
210667 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2020-04-01 SUNSHINE
208898 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2017-11-22 MSN
208850 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2018-10-16 AMNEAL PHARMS CO
208647 NDA EZALLOR SPRINKLE ROSUVASTATIN CALCIUM CAPSULE;ORAL 2018-12-18 SUN PHARM
207752 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 BIOCON PHARMA
207653 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2021-02-05 INVENTIA
207626 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2019-04-09 UMEDICA
207616 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 HETERO LABS LTD V
207453 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-11-23 CADILA PHARMS LTD
207408 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 CHANGZHOU PHARM
207375 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2019-05-07 SHANDONG
207062 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 RENATA
206513 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2019-03-01 ZHEJIANG JINGXIN
206465 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2017-03-21 ALKEM LABS LTD
206434 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 ACCORD HLTHCARE
206381 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2019-04-24 SCIEGEN PHARMS INC
205587 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2017-07-31 LUPIN
201619 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 2016-10-31 TORRENT