药品注册申请号:020397
申请类型:NDA (新药申请)
申请人:COVIS PHARMA BV
申请人全名:COVIS PHARMA BV
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 ZANAFLEX TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Yes Yes AB 1996/11/27 1996/11/27 Prescription
002 ZANAFLEX TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2000/02/04 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/05/27 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2013/11/07 SUPPL 26 Approval Labeling UNKNOWN
2013/03/19 SUPPL 23 Approval Labeling STANDARD
2006/07/28 SUPPL 21 Approval Labeling STANDARD
2002/11/27 SUPPL 14 Approval Labeling STANDARD
2002/05/17 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2002/04/10 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2001/08/22 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2001/08/21 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2001/03/20 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2000/12/07 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2000/08/21 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2000/06/26 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2000/02/04 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/06/15 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1997/10/23 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1997/09/02 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1997/09/02 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/11/27 ORIG 1 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:TIZANIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 4MG 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
020397 001 NDA ZANAFLEX TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription Yes Yes AB 1996/11/27 COVIS PHARMA BV
076280 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2002/06/27 CASI PHARMS INC
076284 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2002/07/03 ANI PHARMS INC
076286 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2002/07/03 DR REDDYS LABS INC
076347 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2002/10/11 EPIC PHARMA LLC
076354 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2003/03/28 MYLAN
076416 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2003/09/29 SUN PHARM INDS INC
076281 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2003/10/20 OXFORD PHARMS
076533 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2004/01/16 APOTEX
091283 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2012/11/28 UNICHEM LABS LTD
208187 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/03/09 ZYDUS PHARMS
211798 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2019/01/25 ALKEM LABS LTD
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