Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020802
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXCEDRIN (MIGRAINE RELIEF) | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2026 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020802Orig1s046lbl.pdf | |
| 05/15/2023 | SUPPL-42 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s042lbl.pdf | |
| 04/17/2023 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s043lbl.pdf | |
| 12/07/2021 | SUPPL-40 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s040lbl.pdf | |
| 11/03/2021 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s038lbl.pdf | |
| 02/27/2020 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020802Orig1s034lbl.pdf | |
| 04/15/2019 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802Orig1s033lbl.pdf | |
| 01/02/2018 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802s033lbl.pdf | |
| 10/12/2017 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf | |
| 07/15/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf | |
| 04/15/2014 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf | |
| 05/21/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf | |
| 10/07/1999 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf |