TREPROSTINIL-美国FDA药品数据库-药物在线

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	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	No	No	AP	2020/05/22	2020/05/22	Prescription
002	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	No	No	AP		2020/05/22	Prescription
003	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	No	No	AP		2020/05/22	Prescription
004	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	No	No	AP		2020/05/22	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
2023/09/18	SUPPL-4（补充）	Approval	Labeling	STANDARD
2022/07/07	SUPPL-3（补充）	Approval	Manufacturing (CMC)	UNKNOWN
2020/05/22	ORIG-1（原始申请）	Approval		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
无

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
无

与本品治疗等效的药品

活性成分:TREPROSTINIL 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:1MG/ML 治疗等效代码:AP

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	RLD	RS	TE Code	产品号批准日期	申请人
021272	001	NDA	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	Yes	Yes	AP	2002/05/21	UNITED THERAP
203649	001	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	No	No	AP	2017/11/30	SANDOZ
209382	001	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	No	No	AP	2019/09/24	ENDO OPERATIONS
206648	001	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	No	No	AP	2019/09/26	TEVA PHARMS USA
210214	001	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	No	No	AP	2020/05/22	DR REDDYS
211574	001	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1MG/ML	Prescription	No	No	AP	2021/02/11	ALEMBIC GLOBAL

活性成分:TREPROSTINIL 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:2.5MG/ML 治疗等效代码:AP

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	RLD	RS	TE Code	产品号批准日期	申请人
021272	002	NDA	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	Yes	Yes	AP	2002/05/21	UNITED THERAP
203649	002	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	No	No	AP	2017/11/30	SANDOZ
209382	002	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	No	No	AP	2019/09/24	ENDO OPERATIONS
206648	002	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	No	No	AP	2019/09/26	TEVA PHARMS USA
210214	002	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	No	No	AP	2020/05/22	DR REDDYS
211574	002	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	2.5MG/ML	Prescription	No	No	AP	2021/02/11	ALEMBIC GLOBAL

活性成分:TREPROSTINIL 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:5MG/ML 治疗等效代码:AP

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	RLD	RS	TE Code	产品号批准日期	申请人
021272	003	NDA	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	Yes	Yes	AP	2002/05/21	UNITED THERAP
203649	003	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	No	No	AP	2017/11/30	SANDOZ
209382	003	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	No	No	AP	2019/09/24	ENDO OPERATIONS
206648	003	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	No	No	AP	2019/09/26	TEVA PHARMS USA
210214	003	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	No	No	AP	2020/05/22	DR REDDYS
211574	003	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	5MG/ML	Prescription	No	No	AP	2021/02/11	ALEMBIC GLOBAL

活性成分:TREPROSTINIL 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:10MG/ML 治疗等效代码:AP

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	RLD	RS	TE Code	产品号批准日期	申请人
021272	004	NDA	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	Yes	Yes	AP	2002/05/21	UNITED THERAP
203649	004	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	No	No	AP	2017/11/30	SANDOZ
209382	004	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	No	No	AP	2019/09/24	ENDO OPERATIONS
206648	004	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	No	No	AP	2019/09/26	TEVA PHARMS USA
210214	004	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	No	No	AP	2020/05/22	DR REDDYS
211574	004	ANDA	TREPROSTINIL	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	10MG/ML	Prescription	No	No	AP	2021/02/11	ALEMBIC GLOBAL