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
ASTEPRO	022203	001	NDA	AZELASTINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/10/15	2008/10/15	MYLAN SPECIALITY LP	Discontinued
ASTEPRO	022203	002	NDA	AZELASTINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.2055MG/SPRAY	No	No	2008/10/15	2009/08/31	MYLAN SPECIALITY LP	Discontinued
ASTEPRO	022371	001	NDA	AZELASTINE HYDROCHRLORIDE	SPRAY, METERED;NASAL	0.1%	No	No	2009/08/31	--	MEDA PHARMS	Prescription
ASTEPRO	022371	002	NDA	AZELASTINE HYDROCHRLORIDE	SPRAY, METERED;NASAL	0.15%	No	No	2009/08/31	--	MEDA PHARMS	Prescription
ASTEPRO ALLERGY	213872	001	NDA	AZELASTINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.2055MG/SPRAY	Yes	Yes	2021/06/17	2021/06/17	BAYER HLTHCARE	Over-the-counter
CHILDREN'S ASTEPRO ALLERGY	213872	002	NDA	AZELASTINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.2055MG/SPRAY	Yes	Yes	2021/06/17	2021/06/17	BAYER HLTHCARE	Over-the-counter