Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 090254
Company: PERRIGO R AND D

Products on ANDA 090254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	None	No	No
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090254s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
07/10/2017	SUPPL-20	Labeling-Package Insert	Label is not available on this site.
07/23/2010	SUPPL-3	Labeling-Package Insert	Label is not available on this site.
05/28/2009	SUPPL-2	Labeling	Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;ORAL; 5MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090765	AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090750	AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091327	BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091130	CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	210622	HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090254	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	204226	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	212266	QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090182	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	201546	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090765	AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090750	AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091327	BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091130	CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090254	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090182	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	201546	TARO
CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	Yes	022155	J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	Yes	022155	J AND J CONSUMER INC

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;ORAL; 5MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090765	AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090750	AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091327	BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091130	CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	210622	HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090254	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	204226	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	212266	QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090182	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	201546	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090765	AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090750	AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091327	BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	091130	CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090254	PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	090182	TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	No	201546	TARO
CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	Yes	022155	J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Over-the-counter	Yes	022155	J AND J CONSUMER INC