NARCAN-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	NARCAN	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1971/04/13	Approved Prior to Jan 1, 1982	Discontinued
002	NARCAN	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	NARCAN	NALOXONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1982/06/14	Discontinued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
1971/04/13	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
2002/10/25	SUPPL-57（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
2002/04/16	SUPPL-55（补充）	Approval	Manufacturing (CMC)	PRIORITY
2002/02/11	SUPPL-54（补充）	Approval	Labeling	PRIORITY	Label Letter
2002/02/11	SUPPL-52（补充）	Approval	Labeling	PRIORITY	Label Letter
2002/01/15	SUPPL-56（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1996/09/06	SUPPL-53（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1995/06/15	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1995/03/20	SUPPL-51（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1992/05/29	SUPPL-31（补充）	Approval	Efficacy-New Indication	PRIORITY
1987/12/07	SUPPL-49（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1987/10/20	SUPPL-48（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1987/02/26	SUPPL-47（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1986/06/04	SUPPL-46（补充）	Approval	Labeling	PRIORITY
1986/06/04	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1986/06/04	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1986/06/04	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1985/07/23	SUPPL-34（补充）	Approval	Labeling	PRIORITY
1984/10/15	SUPPL-35（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1984/09/25	SUPPL-36（补充）	Approval	Manufacturing (CMC)	PRIORITY
1984/09/17	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1984/09/17	SUPPL-38（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY
1983/11/17	SUPPL-33（补充）	Approval	Manufacturing (CMC)	PRIORITY
1983/11/17	SUPPL-32（补充）	Approval	Manufacturing (CMC)	PRIORITY
1983/06/23	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1982/07/23	SUPPL-27（补充）	Approval	Labeling	PRIORITY
1982/06/14	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1982/05/19	SUPPL-26（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/09/30	SUPPL-22（补充）	Approval	Labeling	PRIORITY
1981/06/23	SUPPL-20（补充）	Approval	Manufacturing (CMC)	PRIORITY
1981/05/14	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1981/05/14	SUPPL-23（补充）	Approval	Manufacturing (CMC)	PRIORITY
1981/04/01	SUPPL-21（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/06/17	SUPPL-19（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/11/30	SUPPL-18（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/03/23	SUPPL-17（补充）	Approval	Labeling	PRIORITY
1978/10/20	SUPPL-16（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1976/04/08	SUPPL-14（补充）	Approval	Labeling	PRIORITY
1976/04/06	SUPPL-15（补充）	Approval	Labeling	PRIORITY
1975/09/24	SUPPL-13（补充）	Approval	Labeling	PRIORITY
1975/06/06	SUPPL-11（补充）	Approval	Labeling	PRIORITY
1975/06/05	SUPPL-8（补充）	Approval	Labeling	PRIORITY
1975/04/04	SUPPL-5（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1975/04/04	SUPPL-4（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1975/01/16	SUPPL-7（补充）	Approval	Labeling	PRIORITY
1974/12/09	SUPPL-9（补充）	Approval	Labeling	PRIORITY