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
COLYTE	018983	004	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1984/10/26	MYLAN SPECIALITY LP	Discontinued
COLYTE	018983	005	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1984/10/26	MYLAN SPECIALITY LP	Discontinued
COLYTE	018983	006	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1984/10/26	MYLAN SPECIALITY LP	Discontinued
COLYTE	018983	007	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1987/06/12	MYLAN SPECIALITY LP	Discontinued
COLYTE-FLAVORED	018983	008	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1991/11/14	MYLAN SPECIALITY LP	Discontinued
COLYTE-FLAVORED	018983	009	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1991/11/14	MYLAN SPECIALITY LP	Discontinued
COLYTE	018983	010	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1984/10/26	1989/01/31	MYLAN SPECIALITY LP	Discontinued
COLYTE WITH FLAVOR PACKS	018983	012	NDA	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	FOR SOLUTION;ORAL	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	No	No	1984/10/26	1998/10/08	MYLAN SPECIALITY LP	Discontinued