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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022155
Company: KENVUE BRANDS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter None Yes Yes
CHILDREN'S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/13/2026 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022155Orig1s031lbl.pdf
12/24/2025 SUPPL-29 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s029lbl.pdf
11/26/2024 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf
11/13/2024 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s025lbl.pdf
10/11/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf
04/14/2016 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf
05/16/2014 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf
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