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
INDOCIN	016059	001	NDA	INDOMETHACIN	CAPSULE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1965/06/10	Approved Prior to Jan 1, 1982	ZYLA LIFE SCIENCES	Discontinued
INDOCIN	016059	002	NDA	INDOMETHACIN	CAPSULE;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1965/06/10	Approved Prior to Jan 1, 1982	ZYLA LIFE SCIENCES	Discontinued
INDOCIN SR	018185	001	NDA	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1982/02/23	1982/02/23	ZYLA	Discontinued
INDOCIN	017814	001	NDA	INDOMETHACIN	SUPPOSITORY;RECTAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1984/08/13	1984/08/13	ZYLA LIFE SCIENCES	Discontinued
INDOCIN	018878	001	NDA	INDOMETHACIN SODIUM	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1985/01/30	1985/01/30	RECORDATI RARE	Discontinued
INDOCIN	018332	001	NDA	INDOMETHACIN	SUSPENSION;ORAL	25MG/5ML	Yes	Yes	1985/10/10	1985/10/10	ZYLA	Prescription