Application 076677

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3635	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3637	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
12634-987	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Apotheca Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-597	Cetirizine Hydrochloride	cetirizine hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current
55154-5399	Cetirizine Hydrochloride	cetirizine hydrochloride	Cardinal Health	ANDA	Current

Document	Submission type	Date
8946	ORIG	2008-01-09
18450	ORIG	2008-01-08