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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/14/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2023 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020802Orig1s043ltr.pdf | |
| 05/15/2023 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020802Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020802Orig1s042lbl.pdf | |
| 12/07/2021 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020802Orig1s040ltr.pdf | |
| 11/03/2021 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020802Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020802Orig1s038ltr.pdf | |
| 02/27/2020 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020802Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020802Orig1s034ltr.pdf | |
| 04/15/2019 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020802Orig1s033ltr.pdf | |
| 01/02/2018 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020802s032ltr.pdf | |
| 10/12/2017 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020802s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020802Orig1s031ltr.pdf | |
| 09/13/2017 | SUPPL-30 |
Label is not available on this site. |
|||
| 04/29/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf | |
| 04/15/2014 | SUPPL-22 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s022ltr.pdf | |
| 02/04/2010 | SUPPL-19 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020802s019ltr.pdf |
| 01/31/2007 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020802s015ltr.pdf |
| 08/27/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20802s010ltr.pdf |
| 05/21/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf | |
| 04/19/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.cfm | |
| 10/22/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
EXCEDRIN (MIGRAINE RELIEF)
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 250MG;250MG;65MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | No | 211695 | AUROBINDO PHARMA LTD |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | No | 214039 | GRANULES |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | No | 075794 | PERRIGO |
| EXCEDRIN (MIGRAINE RELIEF) | ACETAMINOPHEN; ASPIRIN; CAFFEINE | 250MG;250MG;65MG | TABLET;ORAL | Over-the-counter | Yes | 020802 | HALEON US HOLDINGS |