APRESOLINE-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	APRESOLINE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1953/01/15	Approved Prior to Jan 1, 1982	Discontinued
002	APRESOLINE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	APRESOLINE	HYDRALAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
004	APRESOLINE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
005	APRESOLINE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	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
1953/01/15	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	PRIORITY

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签
1999/04/28	SUPPL-71（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1997/02/03	SUPPL-70（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1996/08/22	SUPPL-69（补充）	Approval	Manufacturing (CMC)	PRIORITY
1996/02/28	SUPPL-68（补充）	Approval	Labeling	PRIORITY	Label
1994/07/12	SUPPL-67（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1993/12/27	SUPPL-66（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1992/01/03	SUPPL-65（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1991/08/05	SUPPL-64（补充）	Approval	Manufacturing (CMC)	PRIORITY
1991/06/19	SUPPL-63（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1989/03/07	SUPPL-62（补充）	Approval	Labeling	PRIORITY
1986/12/22	SUPPL-59（补充）	Approval	Labeling	PRIORITY
1985/09/13	SUPPL-58（补充）	Approval	Labeling	PRIORITY
1985/04/18	SUPPL-47（补充）	Approval	Labeling	PRIORITY
1985/03/19	SUPPL-57（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1984/09/18	SUPPL-55（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1983/12/15	SUPPL-53（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1983/11/15	SUPPL-52（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1983/07/15	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1982/08/23	SUPPL-49（补充）	Approval	Manufacturing (CMC)	PRIORITY
1982/05/05	SUPPL-48（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/02/27	SUPPL-46（补充）	Approval	Labeling	PRIORITY
1980/05/08	SUPPL-45（补充）	Approval	Labeling	PRIORITY
1980/01/25	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1979/10/04	SUPPL-37（补充）	Approval	Labeling	PRIORITY
1979/10/04	SUPPL-36（补充）	Approval	Labeling	PRIORITY
1979/08/02	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1979/07/31	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1979/05/29	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1979/04/09	SUPPL-40（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1979/04/09	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1979/04/09	SUPPL-38（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1977/12/08	SUPPL-32（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1977/09/07	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1977/07/11	SUPPL-25（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1977/07/11	SUPPL-23（补充）	Approval	Labeling	PRIORITY
1977/07/11	SUPPL-21（补充）	Approval	/	PRIORITY
1977/04/18	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1977/04/18	SUPPL-29（补充）	Approval	Labeling	PRIORITY
1977/04/18	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1976/04/19	SUPPL-24（补充）	Approval	Labeling	PRIORITY