Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201803
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADVIL | IBUPROFEN SODIUM | EQ 200MG BASE | 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 |
---|---|---|---|---|---|---|---|
06/12/2012 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803_advil_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2022 | SUPPL-16 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201803Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201803Orig1s016ltr.pdf | |
05/31/2018 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s012ltr.pdf | |
04/12/2018 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s011ltr.pdf | |
08/22/2017 | SUPPL-9 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s009ltr.pdf | |
06/12/2017 | SUPPL-8 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s008ltr.pdf | |
06/03/2016 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201803Orig1s007ltr.pdf | |
11/05/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/03/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/15/2013 | 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 |
---|---|---|---|---|---|
02/08/2022 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201803Orig1s016lbl.pdf | |
05/31/2018 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf | |
04/12/2018 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf | |
08/22/2017 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf | |
06/12/2017 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf | |
06/03/2016 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf | |
06/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf |
ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; EQ 200MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL | IBUPROFEN SODIUM | EQ 200MG BASE | TABLET;ORAL | Over-the-counter | Yes | 201803 | HALEON US HOLDINGS |