Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020589
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | No | No |
| CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2022 | SUPPL-39 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020589Orig1s039lbl.pdf | |
| 08/30/2018 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf | |
| 06/21/2017 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf | |
| 03/23/2017 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf | |
| 12/20/2013 | SUPPL-29 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf |
| 03/18/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf | |
| 08/02/2001 | SUPPL-13 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf |