Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022578
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/02/2026 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022578Orig1s015lbl.pdf | |
| 07/02/2026 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022578Orig1s015lbl.pdf | |
| 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 |