Application 090750

Type: ANDA
Sponsor: AUROBINDO PHARMA

Related Records

Company: AUROBINDO PHARMA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
55315-354	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	Fred's, Inc.	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-028	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-030	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-422	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
58602-424	Childrens Allergy Relief	Cetirizine Hydrochloride	Aurohealth LLC	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
63868-865	CHILDRENS ALLERGY RELIEF	Cetirizine Hydrochloride	C.D.M.A., Inc.	ANDA	Current
65862-422	Childrens Cetirizine Hydrochloride Allergy	Cetirizine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-443	Childrens Cetirizine Hydrochloride Hives Relief	Cetirizine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current