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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022578
Company: KENVUE BRANDS

Summary Review

Products on NDA 022578

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022578

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022578s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578s000_zyrtec_allergy_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2024	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022578Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022578Orig1s014ltr.pdf
08/23/2016	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022578Orig1s007ltr.pdf
08/01/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/21/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/24/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/01/2011	SUPPL-1	Labeling-Proprietary Name Change	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022578s001ltr.pdf

Labels for NDA 022578

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2024	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022578Orig1s014lbl.pdf
08/23/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf

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

ZYRTEC 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	KENVUE BRANDS

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