药品注册申请号:019194
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH AMERICAS 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 SYPRINE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Yes Yes AB 1985/11/08 1985/11/08 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
2015/03/03 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
2001/05/10 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
2001/01/17 SUPPL-6(补充) Approval Labeling STANDARD
2000/02/08 SUPPL-5(补充) Approval Labeling STANDARD
1998/02/24 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1994/06/24 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1988/02/16 SUPPL-2(补充) Approval Labeling
1986/10/15 SUPPL-1(补充) Approval Labeling ;Orphan
1985/11/08 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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:TRIENTINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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
019194 001 NDA SYPRINE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription Yes Yes AB 1985/11/08 BAUSCH
207567 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2018/02/07 WATSON LABS TEVA
211251 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2019/01/16 NAVINTA LLC
211554 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2019/04/26 ZYDUS PHARMS
211134 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2019/05/22 MSN
211076 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2019/07/03 DR REDDYS
210096 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2019/09/25 ENDO OPERATIONS
212238 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2020/02/20 RISING
209945 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2021/08/13 ECI PHARMS LLC
212929 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Discontinued No No AB 2021/08/30 ACCORD HLTHCARE
216356 001 ANDA TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2022/06/23 HETERO LABS LTD III
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