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
PRILOSEC	019810	001	NDA	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1989/09/14	1989/09/14	ASTRAZENECA	Discontinued
PRILOSEC	019810	002	NDA	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1989/09/14	1998/01/15	ASTRAZENECA	Discontinued
PRILOSEC	019810	003	NDA	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1989/09/14	1995/10/05	ASTRAZENECA	Discontinued
PRILOSEC OTC	021229	001	NDA	OMEPRAZOLE MAGNESIUM	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	Yes	Yes	2003/06/20	2003/06/20	ASTRAZENECA	Over-the-counter
PRILOSEC	022056	001	NDA	OMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 2.5MG BASE/PACKET	Yes	No	2008/03/20	2008/03/20	COVIS	Prescription
PRILOSEC	022056	002	NDA	OMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 10MG BASE/PACKET	Yes	Yes	2008/03/20	2008/03/20	COVIS	Prescription