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
NUBAIN	018024	001	NDA	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/05/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Discontinued
NUBAIN	018024	002	NDA	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20MG/ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/05/15	1982/05/27	ENDO OPERATIONS	Discontinued
NUBAIN	018024	003	NDA	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/05/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Discontinued
NUBAIN	018024	004	NDA	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20MG/2ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/05/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Discontinued
NUBAIN	018024	005	NDA	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	200MG/10ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/05/15	1984/03/02	ENDO OPERATIONS	Discontinued