药品注册申请号:019766
申请类型:NDA (新药申请)
申请人:ORGANON
申请人全名:ORGANON LLC A SUB OF ORGANON AND CO
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 ZOCOR SIMVASTATIN TABLET;ORAL 5MG Yes No AB 1991/12/23 1991/12/23 Prescription
002 ZOCOR SIMVASTATIN TABLET;ORAL 10MG Yes No AB 1991/12/23 Prescription
003 ZOCOR SIMVASTATIN TABLET;ORAL 20MG Yes No AB 1991/12/23 Prescription
004 ZOCOR SIMVASTATIN TABLET;ORAL 40MG Yes No AB 1991/12/23 Prescription
005 ZOCOR SIMVASTATIN TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1998/07/10 Discontinued
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
2023/08/09 SUPPL-104(补充) Approval Labeling STANDARD
2023/03/14 SUPPL-103(补充) Approval Labeling STANDARD
2022/05/31 SUPPL-102(补充) Approval Labeling STANDARD
2022/03/07 SUPPL-99(补充) Approval Labeling STANDARD
2020/09/25 SUPPL-101(补充) Approval Labeling 901 REQUIRED
2019/10/04 SUPPL-100(补充) Approval Labeling STANDARD
2019/03/01 SUPPL-92(补充) Approval Labeling STANDARD
2018/02/28 SUPPL-98(补充) Approval Labeling STANDARD
2016/03/01 SUPPL-95(补充) Approval Manufacturing (CMC) STANDARD
2015/02/02 SUPPL-93(补充) Approval Labeling STANDARD
2014/02/27 SUPPL-91(补充) Approval Labeling STANDARD
2013/10/25 SUPPL-90(补充) Approval Labeling STANDARD
2012/11/15 SUPPL-86(补充) Approval Manufacturing (CMC) STANDARD
2012/10/31 SUPPL-88(补充) Approval Labeling 901 REQUIRED
2012/10/31 SUPPL-87(补充) Approval Labeling UNKNOWN
2012/02/28 SUPPL-85(补充) Approval Labeling UNKNOWN
2011/10/06 SUPPL-83(补充) Approval Labeling UNKNOWN
2011/06/10 SUPPL-79(补充) Approval Labeling UNKNOWN
2011/06/08 SUPPL-82(补充) Approval Labeling 901 REQUIRED
2011/06/08 SUPPL-77(补充) Approval Labeling STANDARD
2010/11/04 SUPPL-81(补充) Approval Labeling UNKNOWN
2010/04/08 SUPPL-80(补充) Approval Labeling UNKNOWN
2010/03/02 SUPPL-78(补充) Approval Labeling UNKNOWN
2008/06/11 SUPPL-76(补充) Approval Labeling STANDARD
2007/11/26 SUPPL-75(补充) Approval Labeling STANDARD
2007/06/01 SUPPL-74(补充) Approval Manufacturing (CMC) N/A
2005/08/31 SUPPL-69(补充) Approval Labeling STANDARD
2005/05/17 SUPPL-70(补充) Approval Labeling STANDARD
2004/02/24 SUPPL-68(补充) Approval Labeling STANDARD
2004/02/24 SUPPL-67(补充) Approval Labeling STANDARD
2003/09/17 SUPPL-66(补充) Approval Labeling STANDARD
2003/09/17 SUPPL-65(补充) Approval Labeling STANDARD
2003/04/16 SUPPL-58(补充) Approval Efficacy STANDARD
2002/10/18 SUPPL-56(补充) Approval Efficacy STANDARD
2002/05/06 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
2002/05/06 SUPPL-51(补充) Approval Labeling STANDARD
2002/03/21 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
2002/03/21 SUPPL-52(补充) Approval Efficacy STANDARD
2002/02/22 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
2001/11/14 SUPPL-53(补充) Approval Labeling STANDARD
2001/11/14 SUPPL-45(补充) Approval Labeling STANDARD
2001/09/13 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
2001/06/04 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
2001/04/10 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
2001/04/10 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
2000/12/11 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
2000/11/07 SUPPL-42(补充) Approval Efficacy UNKNOWN
2000/08/22 SUPPL-39(补充) Approval Labeling STANDARD
2000/04/27 SUPPL-40(补充) Approval Efficacy UNKNOWN
2000/04/14 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
2000/03/15 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1999/11/22 SUPPL-36(补充) Approval Efficacy STANDARD
1999/11/22 SUPPL-34(补充) Approval Efficacy STANDARD
1999/09/15 SUPPL-35(补充) Approval Labeling STANDARD
1999/08/05 SUPPL-32(补充) Approval Efficacy STANDARD
1999/04/23 SUPPL-31(补充) Approval Labeling STANDARD
1999/03/22 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1998/09/24 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1998/07/10 SUPPL-28(补充) Approval Efficacy STANDARD
1998/07/10 SUPPL-26(补充) Approval Efficacy STANDARD
1998/06/29 SUPPL-29(补充) Approval Labeling STANDARD
1998/03/31 SUPPL-27(补充) Approval Efficacy UNKNOWN
1997/12/02 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1997/10/31 SUPPL-21(补充) Approval Efficacy STANDARD
1997/09/09 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1997/08/12 SUPPL-20(补充) Approval Labeling STANDARD
1997/07/18 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1997/05/23 SUPPL-17(补充) Approval Labeling STANDARD
1997/05/19 SUPPL-18(补充) Approval Labeling STANDARD
1997/03/17 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1996/11/22 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1995/11/06 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1995/08/01 SUPPL-15(补充) Approval Labeling STANDARD
1995/08/01 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1995/06/30 SUPPL-11(补充) Approval Efficacy STANDARD
1995/06/09 SUPPL-14(补充) Approval Labeling STANDARD
1995/04/19 SUPPL-8(补充) Approval Labeling STANDARD
1995/02/16 SUPPL-10(补充) Approval Labeling STANDARD
1995/01/23 SUPPL-6(补充) Approval Labeling STANDARD
1994/12/21 SUPPL-9(补充) Approval Labeling STANDARD
1994/07/28 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1994/02/22 SUPPL-5(补充) Approval Labeling STANDARD
1994/02/22 SUPPL-3(补充) Approval Labeling STANDARD
1993/11/24 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1993/08/09 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1992/11/27 SUPPL-1(补充) Approval Labeling STANDARD
1991/12/23 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
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
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
与本品治疗等效的药品
活性成分:SIMVASTATIN 剂型/给药途径:TABLET;ORAL 规格:5MG 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
019766 001 NDA ZOCOR SIMVASTATIN TABLET;ORAL 5MG Prescription Yes No AB 1991/12/23 ORGANON
076685 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077837 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 BIOCON PHARMA
077752 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2008/01/23 DR REDDYS LABS INC
078103 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2009/04/14 LUPIN
078735 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2011/09/16 MICRO LABS
078155 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2013/04/05 ACCORD HLTHCARE
200895 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
活性成分:SIMVASTATIN 剂型/给药途径:TABLET;ORAL 规格:10MG 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
019766 002 NDA ZOCOR SIMVASTATIN TABLET;ORAL 10MG Prescription Yes No AB 1991/12/23 ORGANON
076685 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2007/05/11 LUPIN
078155 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2011/09/16 MICRO LABS
200895 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
活性成分:SIMVASTATIN 剂型/给药途径:TABLET;ORAL 规格:20MG 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
019766 003 NDA ZOCOR SIMVASTATIN TABLET;ORAL 20MG Prescription Yes No AB 1991/12/23 ORGANON
076685 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2007/05/11 LUPIN
078155 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2011/09/16 MICRO LABS
200895 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
活性成分:SIMVASTATIN 剂型/给药途径:TABLET;ORAL 规格:40MG 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
019766 004 NDA ZOCOR SIMVASTATIN TABLET;ORAL 40MG Prescription Yes No AB 1991/12/23 ORGANON
076685 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2007/05/11 LUPIN
078155 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2011/09/16 MICRO LABS
200895 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
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