药品注册申请号：090548
申请类型：ANDA (仿制药申请)
申请人：APOTEX INC
申请人全名：APOTEX INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE No No AB 2012/05/29 2012/05/29 Prescription
002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE No No AB 2012/05/29 Prescription
003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE No No AB 2012/05/29 Prescription
004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE No No AB 2012/05/29 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/12/04 SUPPL-31（补充） Approval Labeling STANDARD
2023/07/25 SUPPL-27（补充） Approval Labeling STANDARD
2023/07/25 SUPPL-26（补充） Approval Labeling STANDARD
2023/07/25 SUPPL-25（补充） Approval Labeling STANDARD
2019/11/04 SUPPL-23（补充） Approval Labeling STANDARD
2019/01/17 SUPPL-19（补充） Approval Labeling STANDARD
2018/06/07 SUPPL-17（补充） Approval Labeling STANDARD
2018/06/07 SUPPL-16（补充） Approval Labeling STANDARD
2015/10/06 SUPPL-11（补充） Approval Labeling STANDARD
2015/04/28 SUPPL-10（补充） Approval Labeling STANDARD
2015/04/06 SUPPL-3（补充） Approval Labeling STANDARD
2012/05/29 ORIG-1（原始申请） Approval
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020702 001 NDA LIPITOR ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 1996/12/17 UPJOHN
076477 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2011/11/30 SUN PHARM INDS LTD
077575 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/05/29 CHARTWELL RX
090548 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/05/29 APOTEX INC
091226 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/05/29 MYLAN PHARMS INC
091650 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/07/17 DR REDDYS LABS LTD
091624 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2013/04/05 LANNETT CO INC
205519 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/05/19 SCIEGEN PHARMS INC
204846 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2017/01/09 INVAGEN PHARMS
205300 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/03/27 TEVA PHARMS USA
207687 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/03/30 ACCORD HLTHCARE
209912 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/06/18 GRAVITI PHARMS
206536 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/11/20 ZYDUS PHARMS
209288 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/12/21 ALKEM LABS LTD
211933 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/02/08 MSN
205945 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/11/07 MICRO LABS LTD INDIA
214659 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/07/14 DR REDDYS
214969 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/09/02 AGNITIO
216848 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2022/11/03 LEPU PHARM
216436 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/11/23 BIOCON PHARMA
214344 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/09/12 HETERO LABS LTD V
212103 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2023/10/16 CADILA PHARMS LTD
217634 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2023/12/21 STRIDES PHARMA
217081 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/01/05 MANKIND PHARMA
214513 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/01/22 LAURUS
211886 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/01/25 SHANDONG XINHUA
217118 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/02/13 AUROBINDO PHARMA LTD
208480 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/06/03 MACLEODS PHARMS LTD
活性成分:ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020702 002 NDA LIPITOR ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription Yes No AB 1996/12/17 UPJOHN
076477 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2011/11/30 SUN PHARM INDS LTD
077575 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/05/29 CHARTWELL RX
090548 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/05/29 APOTEX INC
091226 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/05/29 MYLAN PHARMS INC
091650 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/07/17 DR REDDYS LABS LTD
091624 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2013/04/05 LANNETT CO INC
205519 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/05/19 SCIEGEN PHARMS INC
204846 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2017/01/09 INVAGEN PHARMS
205300 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/03/27 TEVA PHARMS USA
207687 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/03/30 ACCORD HLTHCARE
209912 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/06/18 GRAVITI PHARMS
206536 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/11/20 ZYDUS PHARMS
209288 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/12/21 ALKEM LABS LTD
211933 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/02/08 MSN
205945 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/11/07 MICRO LABS LTD INDIA
214659 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/07/14 DR REDDYS
214969 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/09/02 AGNITIO
216848 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2022/11/03 LEPU PHARM
216436 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2022/11/23 BIOCON PHARMA
214344 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2023/09/12 HETERO LABS LTD V
212103 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2023/10/16 CADILA PHARMS LTD
217634 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2023/12/21 STRIDES PHARMA
217081 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/01/05 MANKIND PHARMA
214513 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/01/22 LAURUS
211886 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/01/25 SHANDONG XINHUA
217118 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/02/13 AUROBINDO PHARMA LTD
208480 002 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/06/03 MACLEODS PHARMS LTD
活性成分:ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 40MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020702 003 NDA LIPITOR ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription Yes No AB 1996/12/17 UPJOHN
076477 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2011/11/30 SUN PHARM INDS LTD
077575 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2012/05/29 CHARTWELL RX
090548 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2012/05/29 APOTEX INC
091226 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2012/05/29 MYLAN PHARMS INC
091650 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2012/07/17 DR REDDYS LABS LTD
091624 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2013/04/05 LANNETT CO INC
205519 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/05/19 SCIEGEN PHARMS INC
204846 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2017/01/09 INVAGEN PHARMS
205300 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2017/03/27 TEVA PHARMS USA
207687 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2018/03/30 ACCORD HLTHCARE
209912 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2018/06/18 GRAVITI PHARMS
206536 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2018/11/20 ZYDUS PHARMS
209288 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2018/12/21 ALKEM LABS LTD
211933 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/02/08 MSN
205945 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/11/07 MICRO LABS LTD INDIA
214659 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2021/07/14 DR REDDYS
214969 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2021/09/02 AGNITIO
216848 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2022/11/03 LEPU PHARM
216436 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2022/11/23 BIOCON PHARMA
214344 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2023/09/12 HETERO LABS LTD V
212103 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2023/10/16 CADILA PHARMS LTD
217634 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2023/12/21 STRIDES PHARMA
217081 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/01/05 MANKIND PHARMA
214513 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/01/22 LAURUS
211886 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/01/25 SHANDONG XINHUA
217118 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/02/13 AUROBINDO PHARMA LTD
208480 003 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/06/03 MACLEODS PHARMS LTD
活性成分:ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 80MG BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020702 004 NDA LIPITOR ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription Yes Yes AB 2000/04/07 UPJOHN
076477 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2011/11/30 SUN PHARM INDS LTD
077575 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2012/05/29 CHARTWELL RX
090548 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2012/05/29 APOTEX INC
091226 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2012/05/29 MYLAN PHARMS INC
202357 001 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2012/07/17 DR REDDYS LABS LTD
091624 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2013/04/05 LANNETT CO INC
205519 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2016/05/19 SCIEGEN PHARMS INC
204846 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Discontinued No No AB 2017/01/09 INVAGEN PHARMS
205300 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2017/03/27 TEVA PHARMS USA
207687 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2018/03/30 ACCORD HLTHCARE
209912 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2018/06/18 GRAVITI PHARMS
206536 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2018/11/20 ZYDUS PHARMS
209288 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2018/12/21 ALKEM LABS LTD
211933 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2019/02/08 MSN
205945 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2019/11/07 MICRO LABS LTD INDIA
214659 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2021/07/14 DR REDDYS
214969 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2021/09/02 AGNITIO
216848 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Discontinued No No AB 2022/11/03 LEPU PHARM
216436 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2022/11/23 BIOCON PHARMA
214344 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2023/09/12 HETERO LABS LTD V
212103 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Discontinued No No AB 2023/10/16 CADILA PHARMS LTD
217634 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Discontinued No No AB 2023/12/21 STRIDES PHARMA
217081 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2024/01/05 MANKIND PHARMA
214513 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2024/01/22 LAURUS
211886 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2024/01/25 SHANDONG XINHUA
217118 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2024/02/13 AUROBINDO PHARMA LTD
208480 004 ANDA ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET;ORAL EQ 80MG BASE Prescription No No AB 2024/06/03 MACLEODS PHARMS LTD
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药品NDC数据与药品包装、标签说明书
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