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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021621
Company: KENVUE BRANDS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes No
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes No
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/16/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21621ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-621_Zyrtec.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2026 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021621Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021621Orig1s018ltr.pdf
08/15/2024 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021621Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021621Orig1s017ltr.pdf
12/14/2021 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Proprietary Name Change Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021621Orig1s012ltr.pdf
11/30/2020 SUPPL-10 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021621Orig1s010ltr.pdf
11/16/2007 SUPPL-5 Efficacy-Rx To OTC Switch Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021621s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.html

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/24/2026 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021621Orig1s018lbl.pdf
03/24/2026 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021621Orig1s018lbl.pdf
08/15/2024 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021621Orig1s017lbl.pdf
12/14/2021 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf
12/14/2021 SUPPL-12 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf
11/30/2020 SUPPL-10 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf

CHILDREN'S 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, CHEWABLE;ORAL; 2.5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021621 KENVUE BRANDS

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

TABLET, CHEWABLE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 206793 NOVEL LABS INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 078692 SANDOZ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021621 KENVUE BRANDS

CHILDREN'S ZYRTEC HIVES RELIEF

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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