M.V.I.-12 ADULT-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
004	M.V.I.-12 ADULT	ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E	INJECTABLE;INJECTION	10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML	No	No	None	1953/02/20	1985/08/08	Discontinued
005	M.V.I.-12 ADULT	ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E	INJECTABLE;INJECTION	20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML	No	No	None		2004/04/22	Discontinued
006	M.V.I.-12 ADULT	ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E	INJECTABLE;INJECTION	20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML	Yes	No	None		2004/09/09	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
1953/02/20	ORIG-1（原始申请）	Approval	Type 4 - New Combination	STANDARD

>>>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
2017/11/09	SUPPL-73（补充）	Approval	Labeling-Container/Carton Labels	STANDARD	Letter Label
2015/09/18	SUPPL-72（补充）	Approval	Manufacturing (CMC)	STANDARD
2015/02/03	SUPPL-67（补充）	Approval	Manufacturing (CMC)	STANDARD
2013/03/26	SUPPL-66（补充）	Approval	Labeling-Package Insert	UNKNOWN	Letter Label
2013/03/19	SUPPL-69（补充）	Approval	Manufacturing (CMC)	STANDARD
2012/06/14	SUPPL-65（补充）	Approval	Labeling	UNKNOWN	Letter Label
2009/11/24	SUPPL-60（补充）	Approval	Labeling-Container/Carton Labels	N/A
2004/09/09	SUPPL-54（补充）	Approval	Efficacy-New Indication	PRIORITY	Letter Label
2004/04/22	SUPPL-52（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD	Label Letter
2002/11/14	SUPPL-48（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
2002/06/04	SUPPL-47（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
2002/06/04	SUPPL-46（补充）	Approval	Labeling	STANDARD	Letter
2001/04/17	SUPPL-45（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/04/17	SUPPL-44（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/04/10	SUPPL-43（补充）	Approval	Manufacturing (CMC)	STANDARD
1999/08/02	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1999/05/25	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1998/11/18	SUPPL-40（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1998/05/12	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1998/03/30	SUPPL-37（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/12/31	SUPPL-38（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1997/09/22	SUPPL-36（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1997/02/13	SUPPL-35（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/01/19	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1995/10/27	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1995/05/26	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/02/24	SUPPL-29（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/02/03	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1993/02/02	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1991/04/19	SUPPL-25（补充）	Approval	Labeling
1990/12/07	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1989/06/22	SUPPL-23（补充）	Approval	Labeling
1985/08/08	SUPPL-21（补充）	Approval	Labeling
1985/04/25	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/04/24	SUPPL-20（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1984/09/20	SUPPL-18（补充）	Approval	Labeling
1980/06/23	SUPPL-5（补充）	Approval	Labeling