药品注册申请号:089685
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG No No AB 1988/12/08 1988/12/08 Prescription
002 PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG No No AB 1988/12/08 Prescription
003 PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG No No AB 1988/12/08 Prescription
004 PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG No Yes AB 1988/12/08 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
2017/02/23 SUPPL-27(补充) Approval Labeling STANDARD
2010/12/06 SUPPL-24(补充) Approval Labeling
2009/05/27 SUPPL-22(补充) Approval Labeling
2008/11/25 SUPPL-21(补充) Approval Labeling
2008/11/19 SUPPL-20(补充) Approval Labeling
2008/05/29 SUPPL-15(补充) Approval Labeling
2002/10/22 SUPPL-13(补充) Approval Labeling
2002/10/22 SUPPL-12(补充) Approval Labeling
2001/05/15 SUPPL-11(补充) Approval Manufacturing (CMC)
2001/02/27 SUPPL-10(补充) Approval Manufacturing (CMC)
1999/05/05 SUPPL-8(补充) Approval Manufacturing (CMC)
1998/10/16 SUPPL-5(补充) Approval Labeling
1998/10/16 SUPPL-4(补充) Approval Manufacturing (CMC)
1998/09/15 SUPPL-7(补充) Approval Manufacturing (CMC)
1998/09/15 SUPPL-6(补充) Approval Manufacturing (CMC)
1995/07/07 SUPPL-3(补充) Approval Manufacturing (CMC)
1991/03/26 SUPPL-2(补充) Approval Labeling
1990/10/01 SUPPL-1(补充) Approval Labeling
1988/12/08 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
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:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:8MG 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
089685 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 1988/12/08 SANDOZ
040226 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 1998/12/31 ENDO OPERATIONS
205973 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2015/12/17 WILSHIRE PHARMS INC
207582 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2016/10/17 WATSON LABS INC
205056 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2019/03/01 RISING
205232 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2020/04/06 ZYDUS PHARMS
210163 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2022/05/18 APPCO
212545 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 8MG Prescription No No AB 2024/05/06 MACLEODS PHARMS LTD
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:2MG 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
089683 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB -- SANDOZ
089685 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 1988/12/08 SANDOZ
040226 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 1998/12/31 ENDO OPERATIONS
205973 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2015/12/17 WILSHIRE PHARMS INC
207582 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2016/10/17 WATSON LABS INC
205056 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2019/03/01 RISING
205232 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2020/04/06 ZYDUS PHARMS
210163 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2022/05/18 APPCO
212545 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 2MG Prescription No No AB 2024/05/06 MACLEODS PHARMS LTD
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:4MG 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
089684 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB -- SANDOZ
089685 003 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 1988/12/08 SANDOZ
040226 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 1998/12/31 ENDO OPERATIONS
205973 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2015/12/17 WILSHIRE PHARMS INC
207582 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2016/10/17 WATSON LABS INC
205056 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2019/03/01 RISING
205232 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2020/04/06 ZYDUS PHARMS
210163 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2022/05/18 APPCO
212545 002 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 4MG Prescription No No AB 2024/05/06 MACLEODS PHARMS LTD
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:16MG 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
089686 001 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription Yes No AB -- SANDOZ
089685 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No Yes AB 1988/12/08 SANDOZ
040226 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 1998/12/31 ENDO OPERATIONS
205973 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2015/12/17 WILSHIRE PHARMS INC
207582 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2016/10/17 WATSON LABS INC
205056 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2019/03/01 RISING
205232 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2020/04/06 ZYDUS PHARMS
210163 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2022/05/18 APPCO
212545 004 ANDA PERPHENAZINE PERPHENAZINE TABLET;ORAL 16MG Prescription No No AB 2024/05/06 MACLEODS PHARMS LTD
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