Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022113
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL ALLERGY AND CONGESTION RELIEF | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;200MG;10MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
| ADVIL MULTI-SYMPTOM COLD & FLU | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;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 |
|---|---|---|---|---|---|---|---|
| 12/21/2011 | 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/2011/022113s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113_advil_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2021 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022113Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022113Orig1s011ltr.pdf | |
| 09/06/2019 | SUPPL-8 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s008ltr.pdf | |
| 07/09/2019 | SUPPL-7 | 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; 022565Orig1s005ltr.pdf | |
| 01/25/2019 | SUPPL-5 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s005ltr.pdf | |
| 02/26/2018 | SUPPL-4 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s004ltr.pdf | |
| 02/26/2018 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s003ltr.pdf | |
| 03/24/2017 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/28/2017 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022113Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/23/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022113Orig1s011lbl.pdf | |
| 09/06/2019 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s008lbl.pdf | |
| 07/09/2019 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf | |
| 01/25/2019 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s005lbl.pdf | |
| 02/26/2018 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf | |
| 02/26/2018 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf | |
| 04/28/2017 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf |
ADVIL ALLERGY AND 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; 4MG;200MG;10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL ALLERGY AND CONGESTION RELIEF | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;200MG;10MG | TABLET;ORAL | Over-the-counter | Yes | 022113 | HALEON US HOLDINGS |
| ADVIL MULTI-SYMPTOM COLD & FLU | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;200MG;10MG | TABLET;ORAL | Over-the-counter | Yes | 022113 | HALEON US HOLDINGS |
ADVIL MULTI-SYMPTOM COLD & FLU
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.