Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019872
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/16/2019 | SUPPL-48 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019872Orig1s048lbl.pdf | |
| 08/26/2016 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf | |
| 12/23/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf | |
| 12/12/2014 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf | |
| 03/06/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf | |
| 12/20/2013 | SUPPL-39 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf | |
| 12/20/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf | |
| 03/26/2013 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf | |
| 12/23/2011 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf | |
| 06/17/2009 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf | |
| 05/29/2003 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf | |
| 05/28/2003 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf | |
| 05/28/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf |