药品名称MIACALCIN
申请号020313产品号002
活性成分CALCITONIN SALMON市场状态处方药
剂型或给药途径SPRAY, METERED;NASAL规格200 IU/SPRAY
治疗等效代码AB参比药物
批准日期1995/08/17申请机构MYLAN IRELAND LTD
化学类型New dosage form审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
57335692015/03/31U-227PDF格式
57595652015/03/31PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020313034APLabel2014/03/13下载
020313034APLetter2014/03/13下载
020313033APLabel2012/04/20下载
020313033APLetter2012/04/23下载
020313029APLabel2009/12/10下载
020313023APReview2007/07/06下载
020313023APLetter2003/08/28下载
020313021APLetter2006/01/20下载
020313000APOther Important Information from FDA2014/03/12下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020313035AP2014/02/27Manufacturing Change or Addition
020313034AP2014/03/11Labeling Revision
020313033AP2012/04/18Labeling Revision
020313029AP2009/10/30Labeling Revision
020313023AP2003/08/22Control Supplement
020313021AP2006/01/06Labeling Revision
020313020AP2002/05/10Control Supplement
020313018AP2001/11/02Manufacturing Change or Addition
020313017AP2000/07/14Control Supplement
020313015AP1999/07/23Control Supplement
020313014AP1999/01/13Manufacturing Change or Addition
020313012AP1998/12/17Manufacturing Change or Addition
020313011AP1998/08/14Manufacturing Change or Addition
020313010AP1998/01/12Labeling Revision
020313008AP1997/09/15Control Supplement
020313007AP1997/08/01Control Supplement
020313006AP1997/04/24Control Supplement
020313005AP1997/03/27Control Supplement
020313004AP1998/12/24Package Change
020313003AP1997/03/07Labeling Revision
020313002AP1996/10/22Labeling Revision
020313000AP1995/08/17Approval