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
ZYRTEC ALLERGY	019835	003	NDA	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No	1995/12/08	2007/11/16	KENVUE BRANDS	Discontinued
ZYRTEC ALLERGY	019835	004	NDA	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	Yes	1995/12/08	2007/11/16	KENVUE BRANDS	Over-the-counter
ZYRTEC HIVES	019835	005	NDA	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No	1995/12/08	2007/11/16	KENVUE BRANDS	Discontinued
ZYRTEC HIVES	019835	006	NDA	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No	1995/12/08	2007/11/16	KENVUE BRANDS	Discontinued
ZYRTEC	020346	001	NDA	CETIRIZINE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1996/09/27	1996/09/27	J AND J CONSUMER INC	Discontinued
ZYRTEC-D 12 HOUR	021150	002	NDA	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;120MG	Yes	Yes	2001/08/10	2007/11/09	KENVUE BRANDS	Over-the-counter
CHILDREN'S ZYRTEC ALLERGY	021621	003	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/03/16	2007/11/16	KENVUE BRANDS	Discontinued
CHILDREN'S ZYRTEC ALLERGY	021621	004	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	Yes	No	2004/03/16	2007/11/16	KENVUE BRANDS	Over-the-counter
CHILDREN'S ZYRTEC HIVES RELIEF	021621	005	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/03/16	2007/11/16	KENVUE BRANDS	Discontinued
CHILDREN'S ZYRTEC HIVES RELIEF	021621	006	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/03/16	2007/11/16	KENVUE BRANDS	Discontinued
CHILDREN'S ZYRTEC ALLERGY	021621	007	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	2.5MG	Yes	No	2004/03/16	2020/11/30	KENVUE BRANDS	Over-the-counter
CHILDREN'S ZYRTEC HIVES	022155	001	NDA	CETIRIZINE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	Yes	Yes	2007/11/16	2007/11/16	KENVUE BRANDS	Over-the-counter
CHILDREN'S ZYRTEC ALLERGY	022155	002	NDA	CETIRIZINE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	Yes	Yes	2007/11/16	2007/11/16	KENVUE BRANDS	Over-the-counter
ZYRTEC ALLERGY	022578	001	NDA	CETIRIZINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	Yes	2010/09/03	2010/09/03	KENVUE BRANDS	Over-the-counter