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
ORTHO TRI-CYCLEN	019697	001	NDA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1992/07/03	1992/07/03	JANSSEN PHARMS	Discontinued
ORTHO TRI-CYCLEN	019697	002	NDA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-21	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1992/07/03	1992/07/03	JANSSEN PHARMS	Discontinued
ORTHO TRI-CYCLEN LO	021241	001	NDA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2002/08/22	2002/08/22	JANSSEN PHARMS	Discontinued
ORTHO TRI-CYCLEN 21	021690	001	NDA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET; ORAL-21	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	No	No	2005/05/13	--	ORTHO MCNEIL PHARM	Prescription
ORTHO TRI-CYCLEN 28	021690	002	NDA	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET; ORAL-28	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	No	No	2005/05/13	--	ORTHO MCNEIL PHARM	Prescription