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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/08/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019872Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019872Orig1s048ltr.pdf | |
| 08/26/2016 | SUPPL-44 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf | |
| 05/05/2016 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s042ltr.pdf | |
| 12/12/2014 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s041ltr.pdf | |
| 03/06/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s040ltr.pdf | |
| 12/20/2013 | SUPPL-39 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s039ltr.pdf | |
| 03/28/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2013 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s037ltr.pdf | |
| 12/23/2011 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019872s36ltr.pdf | |
| 05/10/2010 | SUPPL-34 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s034ltr.pdf |
| 05/06/2010 | SUPPL-33 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s033ltr.pdf |
| 09/18/2009 | SUPPL-32 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/17/2009 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019872s031ltr.pdf | |
| 02/28/2008 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019872Orig1_s029.pdf |
| 11/03/2004 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872s021ltr.pdf |
| 04/13/2004 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872slr018ltr.pdf |
| 03/22/2004 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872scp017ltr.pdf |
| 08/01/2003 | SUPPL-16 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872scs016ltr.pdf |
| 05/28/2003 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr014ltr.pdf | |
| 05/28/2003 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr013ltr.pdf | |
| 05/29/2003 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr012ltr.pdf | |
| 02/12/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/25/2000 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019872Orig1s009.pdf |
| 01/11/2001 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019872Orig1s006.pdf |
| 08/01/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1995 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/23/1994 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| 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 |
TYLENOL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 650MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207229 | AUROBINDO PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 211544 | GRANULES |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215486 | MARKSANS PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076200 | OHM LABS |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075077 | PERRIGO |
| TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 019872 | KENVUE BRANDS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 650MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 207229 | AUROBINDO PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 211544 | GRANULES |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215486 | MARKSANS PHARMA |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076200 | OHM LABS |
| ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 075077 | PERRIGO |
| TYLENOL | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 019872 | KENVUE BRANDS |