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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ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/28/2026 SUPPL-19 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021621Orig1s019lbl.pdf
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-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf
12/14/2021 SUPPL-12 Labeling-Container/Carton Labels 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
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