DALMANE-美国FDA药品数据库-药物在线

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	DALMANE	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None	1970/04/07	Approved Prior to Jan 1, 1982	Discontinued
002	DALMANE	FLURAZEPAM HYDROCHLORIDE	CAPSULE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	Approved Prior to Jan 1, 1982	Discontinued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
1970/04/07	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	PRIORITY	Medication Guide Other Important Information from FDA

>>>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
2009/03/27	SUPPL-77（补充）	Approval	Labeling	PRIORITY	Label Letter
2007/10/30	SUPPL-76（补充）	Approval	Labeling	PRIORITY	Letter Label
2002/08/12	SUPPL-75（补充）	Approval	Manufacturing (CMC)	PRIORITY
2001/06/14	SUPPL-74（补充）	Approval	Labeling	PRIORITY	Letter
1993/05/25	SUPPL-72（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1992/12/31	SUPPL-71（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1990/04/25	SUPPL-70（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1990/01/16	SUPPL-68（补充）	Approval	Manufacturing (CMC)	PRIORITY
1989/11/07	SUPPL-67（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1987/11/09	SUPPL-66（补充）	Approval	Labeling	PRIORITY
1984/12/11	SUPPL-64（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1982/06/15	SUPPL-63（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1982/01/28	SUPPL-62（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/12/22	SUPPL-61（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1981/12/22	SUPPL-60（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1981/11/05	SUPPL-59（补充）	Approval	Manufacturing (CMC)	PRIORITY
1981/08/04	SUPPL-57（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/07/17	SUPPL-56（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/05/06	SUPPL-54（补充）	Approval	Labeling	PRIORITY
1981/03/26	SUPPL-55（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1980/08/20	SUPPL-52（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1980/08/20	SUPPL-51（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1980/07/11	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1980/06/17	SUPPL-49（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1980/06/17	SUPPL-48（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1980/02/04	SUPPL-47（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/11/09	SUPPL-46（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/09/17	SUPPL-45（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/05/01	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1979/03/26	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1978/07/28	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1978/07/20	SUPPL-40（补充）	Approval	Labeling	PRIORITY
1978/07/12	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1978/07/10	SUPPL-39（补充）	Approval	Labeling	PRIORITY
1978/07/10	SUPPL-30（补充）	Approval	Labeling	PRIORITY
1978/05/02	SUPPL-38（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/08/02	SUPPL-34（补充）	Approval	Labeling	PRIORITY
1977/07/12	SUPPL-37（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1977/06/29	SUPPL-36（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1976/12/10	SUPPL-32（补充）	Approval	Labeling	PRIORITY
1975/07/01	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1975/01/16	SUPPL-25（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1974/09/17	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1974/04/22	SUPPL-23（补充）	Approval	Labeling	PRIORITY