Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022565
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | 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 |
---|---|---|---|---|---|---|---|
05/27/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022565s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/19/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022565orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022565Orig1s009ltr.pdf | |
07/30/2020 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022565Orig1s006ltr.pdf | |
07/09/2019 | SUPPL-5 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s007;%20022565Orig1s005ltr.pdf | |
03/24/2017 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022565Orig1s003ltr.pdf | |
03/30/2015 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/19/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022565orig1s009lbl.pdf | |
07/30/2020 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf | |
07/09/2019 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf | |
03/24/2017 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf | |
03/30/2015 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf |
ADVIL CONGESTION 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; 200MG;10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | Yes | 022565 | HALEON US HOLDINGS |
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | No | 203200 | PERRIGO R AND D |