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
RISPERDAL	020272	001	NDA	RISPERIDONE	TABLET;ORAL	1MG	Yes	Yes	1993/12/29	1993/12/29	JANSSEN PHARMS	Prescription
RISPERDAL	020272	002	NDA	RISPERIDONE	TABLET;ORAL	2MG	Yes	No	1993/12/29	1993/12/29	JANSSEN PHARMS	Prescription
RISPERDAL	020272	003	NDA	RISPERIDONE	TABLET;ORAL	3MG	Yes	No	1993/12/29	1993/12/29	JANSSEN PHARMS	Prescription
RISPERDAL	020272	004	NDA	RISPERIDONE	TABLET;ORAL	4MG	Yes	No	1993/12/29	1993/12/29	JANSSEN PHARMS	Prescription
RISPERDAL	020272	005	NDA	RISPERIDONE	TABLET;ORAL	5MG	No	No	1993/12/29	1993/12/29	JANSSEN PHARMS	Discontinued
RISPERDAL	020272	007	NDA	RISPERIDONE	TABLET;ORAL	0.5MG	Yes	No	1993/12/29	1999/01/27	JANSSEN PHARMS	Prescription
RISPERDAL	020272	008	NDA	RISPERIDONE	TABLET;ORAL	0.25MG	Yes	No	1993/12/29	1999/05/10	JANSSEN PHARMS	Prescription
RISPERDAL	020588	001	NDA	RISPERIDONE	SOLUTION;ORAL	1MG/ML	Yes	Yes	1996/06/10	1996/06/10	JANSSEN PHARMS	Prescription
RISPERDAL	021444	001	NDA	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/04/02	2003/04/02	JANSSEN PHARMS	Discontinued
RISPERDAL	021444	002	NDA	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/04/02	2003/04/02	JANSSEN PHARMS	Discontinued
RISPERDAL	021444	003	NDA	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/04/02	2003/04/02	JANSSEN PHARMS	Discontinued
RISPERDAL	021444	004	NDA	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/04/02	2004/12/23	JANSSEN PHARMS	Discontinued
RISPERDAL	021444	005	NDA	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/04/02	2004/12/23	JANSSEN PHARMS	Discontinued
RISPERDAL CONSTA	021346	001	NDA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	25MG/VIAL	Yes	Yes	2003/10/29	2003/10/29	JANSSEN PHARMS	Prescription
RISPERDAL CONSTA	021346	002	NDA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	37.5MG/VIAL	Yes	No	2003/10/29	2003/10/29	JANSSEN PHARMS	Prescription
RISPERDAL CONSTA	021346	003	NDA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	50MG/VIAL	Yes	No	2003/10/29	2003/10/29	JANSSEN PHARMS	Prescription
RISPERDAL CONSTA	021346	004	NDA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	12.5MG/VIAL	Yes	No	2003/10/29	2007/04/12	JANSSEN PHARMS	Prescription