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
PROMETHAZINE HYDROCHLORIDE PLAIN	008381	004	NDA	PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1952/04/11	1984/04/18	ANI PHARMS	Discontinued
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	011265	002	NDA	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	15MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1957/12/03	1984/04/02	ANI PHARMS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083204	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	1973/03/06	Approved Prior to Jan 1, 1982	WATSON LABS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083604	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No	1973/09/17	Approved Prior to Jan 1, 1982	IVAX SUB TEVA PHARMS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083312	001	ANDA	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	Yes	Yes	1973/09/19	Approved Prior to Jan 1, 1982	WEST-WARD PHARMS INT	Prescription
PROMETHAZINE HYDROCHLORIDE	083312	002	ANDA	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	Yes	Yes	1973/09/19	Approved Prior to Jan 1, 1982	WEST-WARD PHARMS INT	Prescription
PROMETHAZINE HYDROCHLORIDE	083426	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	1973/09/19	Approved Prior to Jan 1, 1982	WATSON LABS	Prescription
PROMETHAZINE HYDROCHLORIDE	083613	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	1973/09/21	Approved Prior to Jan 1, 1982	IVAX SUB TEVA PHARMS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083711	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	1973/09/21	Approved Prior to Jan 1, 1982	WATSON LABS	Prescription
PROMETHAZINE HYDROCHLORIDE	083712	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No	1973/09/21	Approved Prior to Jan 1, 1982	WATSON LABS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083603	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	1973/10/26	Approved Prior to Jan 1, 1982	IVAX SUB TEVA PHARMS	Discontinued
PROMETHAZINE HYDROCHLORIDE	083838	002	ANDA	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No	1974/01/21	Approved Prior to Jan 1, 1982	HOSPIRA	Discontinued
PROMETHAZINE HYDROCHLORIDE	080629	002	ANDA	PROMETHAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No	1974/01/29	Approved Prior to Jan 1, 1982	WATSON LABS	Discontinued
PROMETHAZINE HYDROCHLORIDE	084214	002	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	1974/08/14	1982/07/07	IMPAX LABS	Discontinued
PROMETHAZINE HYDROCHLORIDE	084176	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	Yes	Yes	1975/02/18	Approved Prior to Jan 1, 1982	SANDOZ	Prescription
PROMETHAZINE HYDROCHLORIDE	084176	002	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No	1975/02/18	2009/05/22	SANDOZ	Discontinued
PROMETHAZINE HYDROCHLORIDE	084176	003	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	Yes	No	1975/02/18	Approved Prior to Jan 1, 1982	SANDOZ	Prescription
PROMETHAZINE HYDROCHLORIDE	084554	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	1975/07/29	Approved Prior to Jan 1, 1982	SUN PHARM INDUSTRIES	Discontinued
PROMETHAZINE HYDROCHLORIDE	084557	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	1975/07/29	Approved Prior to Jan 1, 1982	SUN PHARM INDUSTRIES	Discontinued
PROMETHAZINE HYDROCHLORIDE	080949	001	ANDA	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No	1976/07/28	Approved Prior to Jan 1, 1982	CHARTWELL MOLECULAR	Discontinued