OPHTHETIC(PROPARACAINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	OPHTHETIC
申请号	012583	产品号	001
活性成分	PROPARACAINE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	SOLUTION/DROPS;OPHTHALMIC	规格	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	ALLERGAN PHARMACEUTICAL
化学类型	New dosage form	审评分类	Priority 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
无
历史专利信息
无

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
012583	038	AP	2002/04/12	Control Supplement
012583	037	AP	2002/06/20	Manufacturing Change or Addition
012583	035	AP	2001/04/12	Manufacturing Change or Addition
012583	034	AP	2001/03/12	Control Supplement
012583	033	AP	2000/10/02	Manufacturing Change or Addition
012583	032	AP	1997/10/17	Control Supplement
012583	031	AP	1997/09/18	Control Supplement
012583	030	AP	1997/03/17	Control Supplement
012583	029	AP	1995/05/05	Control Supplement
012583	028	AP	2002/06/20	Labeling Revision
012583	027	AP	1995/08/03	Control Supplement
012583	026	AP	1993/03/04	Formulation Revision
012583	025	AP	1990/02/05	Manufacturing Change or Addition
012583	024	AP	1990/02/05	Control Supplement
012583	023	AP	1989/03/20	Control Supplement
012583	022	AP	1989/10/13	Manufacturing Change or Addition
012583	019	AP	1987/04/21	Practioner Draft Labeling
012583	018	AP	1982/05/21	Manufacturing Change or Addition
012583	017	AP	1982/05/21	Manufacturing Change or Addition
012583	016	AP	1980/05/22	Manufacturing Change or Addition
012583	015	AP	1979/10/04	Control Supplement
012583	011	AP	1977/07/14	Control Supplement
012583	010	AP	1976/09/23	Labeling Revision
012583	009	AP	1976/09/10	Control Supplement
012583	008	AP	1976/09/23	Labeling Revision
012583	007	AP	1976/09/10	Control Supplement
012583	006	AP	1975/09/17	Labeling Revision
012583	005	AP	1975/07/01	Control Supplement
012583	000	AP	1961/01/23	Approval