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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205490
Company: PERRIGO R AND D

Products on ANDA 205490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2015	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205490Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2016	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 205490

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf

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

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.

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	213557	AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	205490	PERRIGO R AND D
ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	Yes	022578	J AND J CONSUMER INC

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