美国FDA药品数据库-药物在线

商品名	申请号	产品号	申请类型	活性成分	剂型/给药途径	规格/剂量	RLD	RS	申请号原始批准/暂定批准日期	产品号批准日期	申请人	市场状态
ZENPEP	022210	001	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	24,000USP UNITS;5,000USP UNITS;17,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	002	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	42,000USP UNITS;10,000USP UNITS;32,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	003	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	63,000USP UNITS;15,000USP UNITS;47,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	004	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	84,000USP UNITS;20,000USP UNITS;63,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	005	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	14,000USP UNITS;3,000USP UNITS;10,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	006	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	105,000USP UNITS;25,000USP UNITS;79,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription
ZENPEP	022210	007	BLA	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	CAPSULE, DELAYED RELEASE;ORAL	168,000USP UNITS;40,000USP UNITS;126,000USP UNITS	No	No	2009/08/27	--	EURAND PHARMA LTD	Prescription