MINOCYCLINE HYDROCHLORIDE-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	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	No	No	AB	2009/08/13	2009/08/13	Prescription
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	No	No	AB		2009/08/13	Prescription
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	No	No	AB		2009/08/13	Prescription
004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE; ORAL	EQ 65MG BASE	No	No	None		--	None (Tentative Approval)
005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE; ORAL	EQ 115MG BASE	No	No	None		--	None (Tentative Approval)
006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE; ORAL	EQ 55MG BASE	No	No	None		--	None (Tentative Approval)
007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Tablet, Extended Release; Oral	EQ 80MG BASE	No	No	None		--	None (Tentative Approval)
008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Tablet, Extended Release; Oral	EQ 105MG BASE	No	No	None		--	None (Tentative Approval)

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

提交状态日期	提交号	审批结论	申请内容分类	审评优先级；罕用药状态
2015/08/26	SUPPL-11（补充）	Approval	Labeling	STANDARD
2013/07/02	SUPPL-8（补充）	Approval	Labeling
2012/12/21	SUPPL-6（补充）	Tentative Approval	Manufacturing (CMC)	UNKNOWN
2011/01/21	SUPPL-3（补充）	Approval	Labeling
2009/08/13	ORIG-1（原始申请）	Approval

与本品相关的专利信息（来自FDA橙皮书Orange Book）

关联产品号	专利号	专利过期日	是否物质专利	是否产品专利	专利用途代码	撤销请求	提交日期	专利下载	备注
无

与本品相关的市场独占权保护信息

关联产品号	独占权代码	失效日期	备注
无

与本品治疗等效的药品

活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 45MG BASE 治疗等效代码:AB

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
090422	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Prescription	No	No	AB	2009/08/13	SANDOZ
091424	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Prescription	No	No	AB	2011/11/30	CHARTWELL RX
202261	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Prescription	No	No	AB	2012/11/19	AUROBINDO PHARMA LTD
091118	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Discontinued	No	No	AB	2014/09/25	SUN PHARM INDS LTD
204394	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Prescription	No	No	AB	2015/12/30	SUN PHARM
204453	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Prescription	No	No	AB	2016/09/28	ALKEM LABS LTD
203553	001	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	Discontinued	No	No	AB	2017/11/16	ZYDUS PHARMS

活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 90MG BASE 治疗等效代码:AB

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
090422	002	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Prescription	No	No	AB	2009/08/13	SANDOZ
091424	003	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Prescription	No	No	AB	2011/11/30	CHARTWELL RX
202261	003	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Prescription	No	No	AB	2012/11/19	AUROBINDO PHARMA LTD
091118	005	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Discontinued	No	No	AB	2014/09/25	SUN PHARM INDS LTD
204453	003	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Prescription	No	No	AB	2016/09/28	ALKEM LABS LTD
203553	005	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	Discontinued	No	No	AB	2017/11/16	ZYDUS PHARMS

活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 135MG BASE 治疗等效代码:AB

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
090422	003	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Prescription	No	No	AB	2009/08/13	SANDOZ
091424	004	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Prescription	No	No	AB	2011/11/30	CHARTWELL RX
202261	005	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Prescription	No	No	AB	2012/11/19	AUROBINDO PHARMA LTD
091118	008	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Discontinued	No	No	AB	2014/09/25	SUN PHARM INDS LTD
204394	007	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Prescription	No	No	AB	2015/12/30	SUN PHARM
204453	005	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Prescription	No	Yes	AB	2016/09/28	ALKEM LABS LTD
203553	008	ANDA	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	Discontinued	No	No	AB	2017/11/16	ZYDUS PHARMS