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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021150
Company: KENVUE BRANDS

Products on NDA 021150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYRTEC-D 12 HOUR	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2001	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21150ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-150_Zyrtec-D.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2024	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021150Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021150Orig1s022ltr.pdf
11/03/2021	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021150Orig1s021bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021150Orig1s021ltr.pdf
03/09/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/03/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/12/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/23/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/09/2007	SUPPL-7	Efficacy-Rx To OTC Switch	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/21150s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021150s007TOC.html
03/17/2004	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf
04/14/2003	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21150se8-002ltr.pdf
02/14/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021150

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2024	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021150Orig1s022lbl.pdf
11/03/2021	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021150Orig1s021bl.pdf
03/17/2004	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf
04/14/2003	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf
08/10/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf

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

ZYRTEC-D 12 HOUR

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

TABLET, EXTENDED RELEASE;ORAL; 5MG;120MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	077170	IVAX SUB TEVA PHARMS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	077991	PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	210719	PPI-DAC
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	090922	SUN PHARM INDS LTD
ZYRTEC-D 12 HOUR	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	021150	KENVUE BRANDS

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