Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212266
Company: QUAGEN

• Medication Guide

Products on ANDA 212266

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2019	ORIG-1	Approval		STANDARD	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf

Labels for ANDA 212266

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf

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