Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020516
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
| MOTRIN IB | IBUPROFEN | 200MG/10ML | SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2026 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020516Orig1s045lbl.pdf | |
| 02/19/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020516Orig1s038lbl.pdf | |
| 11/29/2018 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf | |
| 03/14/2017 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf | |
| 03/14/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf | |
| 06/16/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf | |
| 04/16/2015 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf | |
| 12/11/2014 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf | |
| 09/13/1999 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf |