药品注册申请号:019758
申请类型:NDA (新药申请)
申请人:HERITAGE LIFE
申请人全名:HERITAGE LIFE SCIENCES BARBADOS 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 CLOZARIL CLOZAPINE TABLET;ORAL 25MG Yes No AB 1989/09/26 1989/09/26 Prescription
002 CLOZARIL CLOZAPINE TABLET;ORAL 100MG Yes Yes AB 1989/09/26 Prescription
003 CLOZARIL CLOZAPINE TABLET;ORAL 50MG Yes No AB 2019/05/20 Discontinued
004 CLOZARIL CLOZAPINE TABLET;ORAL 200MG Yes No AB 2019/05/20 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
2024/09/12 SUPPL-104(补充) Approval Labeling STANDARD
2023/05/19 SUPPL-103(补充) Approval Labeling STANDARD
2022/12/19 SUPPL-101(补充) Approval Labeling STANDARD
2021/11/10 SUPPL-99(补充) Approval REMS N/A
2021/07/29 SUPPL-98(补充) Approval REMS N/A
2021/02/18 SUPPL-96(补充) Approval REMS N/A
2021/02/11 SUPPL-88(补充) Approval Labeling STANDARD
2020/04/14 SUPPL-95(补充) Approval Labeling 901 REQUIRED
2019/01/16 SUPPL-90(补充) Approval REMS N/A
2017/02/23 SUPPL-84(补充) Approval Labeling 901 REQUIRED
2017/01/26 SUPPL-81(补充) Approval Labeling STANDARD
2016/12/20 SUPPL-80(补充) Approval Labeling STANDARD
2016/05/06 SUPPL-79(补充) Approval Manufacturing (CMC) PRIORITY
2015/11/10 SUPPL-76(补充) Approval Manufacturing (CMC) PRIORITY
2015/10/08 SUPPL-78(补充) Approval Labeling STANDARD
2015/09/18 SUPPL-74(补充) Approval Labeling STANDARD
2015/09/15 SUPPL-77(补充) Approval Labeling STANDARD
2015/09/15 SUPPL-61(补充) Approval REMS N/A
2014/12/19 SUPPL-73(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-64(补充) Approval Manufacturing (CMC) PRIORITY
2014/09/29 SUPPL-72(补充) Approval Labeling STANDARD
2013/07/19 SUPPL-71(补充) Approval Labeling STANDARD
2013/07/19 SUPPL-69(补充) Approval Labeling STANDARD
2013/03/22 SUPPL-70(补充) Approval Labeling STANDARD
2013/03/22 SUPPL-68(补充) Approval Labeling STANDARD
2013/03/22 SUPPL-67(补充) Approval Labeling STANDARD
2011/10/19 SUPPL-63(补充) Approval Labeling UNKNOWN
2010/12/01 SUPPL-65(补充) Approval Labeling 901 REQUIRED
2010/01/14 SUPPL-62(补充) Approval Labeling STANDARD
2008/11/06 SUPPL-53(补充) Approval Labeling STANDARD
2008/08/14 SUPPL-59(补充) Approval Labeling STANDARD
2008/06/26 SUPPL-58(补充) Approval Labeling STANDARD
2005/12/05 SUPPL-57(补充) Approval Labeling STANDARD
2005/06/29 SUPPL-56(补充) Approval Labeling STANDARD
2005/05/12 SUPPL-54(补充) Approval Labeling STANDARD
2003/12/23 SUPPL-51(补充) Approval Labeling STANDARD
2002/12/18 SUPPL-47(补充) Approval Efficacy PRIORITY
2002/07/05 SUPPL-48(补充) Approval Labeling STANDARD
2002/01/14 SUPPL-45(补充) Approval Labeling STANDARD
2001/12/14 SUPPL-46(补充) Approval Manufacturing (CMC) PRIORITY
2001/08/29 SUPPL-44(补充) Approval Labeling STANDARD
2001/05/18 SUPPL-43(补充) Approval Manufacturing (CMC) PRIORITY
2000/05/17 SUPPL-42(补充) Approval Manufacturing (CMC) PRIORITY
2000/03/17 SUPPL-41(补充) Approval Labeling STANDARD
1999/11/01 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
1999/10/15 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1999/08/09 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/15 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
1998/08/19 SUPPL-36(补充) Approval Labeling STANDARD
1998/03/03 SUPPL-34(补充) Approval Labeling STANDARD
1997/09/19 SUPPL-35(补充) Approval Labeling STANDARD
1997/06/27 SUPPL-32(补充) Approval Labeling STANDARD
1997/04/25 SUPPL-33(补充) Approval Labeling STANDARD
1997/04/25 SUPPL-27(补充) Approval Labeling STANDARD
1997/04/25 SUPPL-25(补充) Approval Labeling STANDARD
1997/04/25 SUPPL-23(补充) Approval Labeling STANDARD
1997/01/13 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1996/05/07 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1995/11/22 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1995/10/17 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/31 SUPPL-16(补充) Approval Labeling STANDARD
1995/08/31 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1995/05/10 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1995/03/07 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1994/08/30 SUPPL-22(补充) Approval Labeling STANDARD
1994/08/05 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1994/08/01 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1994/07/15 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1994/05/20 SUPPL-21(补充) Approval Labeling STANDARD
1994/03/25 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1994/03/25 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1994/03/25 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1992/10/27 SUPPL-10(补充) Approval Labeling
1992/08/20 SUPPL-14(补充) Approval Labeling
1992/08/10 SUPPL-11(补充) Approval Labeling
1991/09/04 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1991/06/12 SUPPL-8(补充) Approval Labeling
1991/06/12 SUPPL-6(补充) Approval Labeling
1991/06/12 SUPPL-5(补充) Approval Labeling
1991/06/12 SUPPL-2(补充) Approval Labeling
1990/02/05 SUPPL-1(补充) Approval Labeling
1989/09/26 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
019758 001 NDA CLOZARIL CLOZAPINE TABLET;ORAL 25MG Prescription Yes No AB 1989/09/26 HERITAGE LIFE
074949 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Prescription No No AB 1997/11/26 IVAX SUB TEVA PHARMS
075417 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Prescription No No AB 1999/05/27 MYLAN
075713 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Prescription No No AB 2002/11/15 SUN PHARM INDS INC
203807 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Discontinued No No AB 2015/09/17 DR REDDYS LABS SA
202873 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Prescription No No AB 2015/11/25 ACCORD HLTHCARE
206433 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 25MG Prescription No No AB 2016/11/29 AUROBINDO PHARMA
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
019758 002 NDA CLOZARIL CLOZAPINE TABLET;ORAL 100MG Prescription Yes Yes AB 1989/09/26 HERITAGE LIFE
074949 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 1997/11/26 IVAX SUB TEVA PHARMS
075417 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 1999/05/27 MYLAN
075713 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 2002/11/15 SUN PHARM INDS INC
076809 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 2005/12/16 IVAX SUB TEVA PHARMS
203807 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Discontinued No No AB 2015/09/17 DR REDDYS LABS SA
202873 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 2015/11/25 ACCORD HLTHCARE
206433 003 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 100MG Prescription No No AB 2016/11/29 AUROBINDO PHARMA
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
074949 004 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Prescription No No AB 2005/04/25 IVAX SUB TEVA PHARMS
075713 003 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Prescription No No AB 2005/08/19 SUN PHARM INDS INC
076809 003 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Prescription No No AB 2005/12/16 IVAX SUB TEVA PHARMS
075417 004 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Prescription No No AB 2010/04/15 MYLAN
206433 002 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Prescription No No AB 2016/11/29 AUROBINDO PHARMA
203807 003 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 50MG Discontinued No No AB 2017/08/22 DR REDDYS LABS SA
019758 003 NDA CLOZARIL CLOZAPINE TABLET;ORAL 50MG Discontinued Yes No AB 2019/05/20 HERITAGE LIFE
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
076809 001 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 200MG Prescription No No AB 2005/12/16 IVAX SUB TEVA PHARMS
075417 005 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 200MG Prescription No No AB 2010/04/15 MYLAN
206433 004 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 200MG Prescription No No AB 2016/11/29 AUROBINDO PHARMA
203807 004 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 200MG Discontinued No No AB 2017/08/22 DR REDDYS LABS SA
075713 004 ANDA CLOZAPINE CLOZAPINE TABLET;ORAL 200MG Prescription No No AB 2017/11/07 SUN PHARM INDS INC
019758 004 NDA CLOZARIL CLOZAPINE TABLET;ORAL 200MG Discontinued Yes No AB 2019/05/20 HERITAGE LIFE
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