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 |
207296 | ANDA | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | MACLEODS PHARMS LTD | |
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 |