Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020402
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | None | Yes | Yes |
| ADVIL MIGRAINE LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/20/1995 | 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 |
|---|---|---|---|---|---|
| 02/23/2023 | SUPPL-55 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020402Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020402Orig1s055ltr.pdf | |
| 01/25/2022 | SUPPL-53 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020402Orig1s053lbl.pdf | |
| 08/31/2018 | SUPPL-47 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s047ltr.pdf | |
| 08/02/2018 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s046Ltr.pdf | |
| 10/18/2017 | SUPPL-44 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s044ltr.pdf | |
| 08/08/2017 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s043ltr.pdf | |
| 03/08/2017 | SUPPL-42 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s042ltr.pdf | |
| 12/17/2015 | SUPPL-40 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020402Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020402Orig1s040ltr.pdf | |
| 09/12/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2012 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/2011 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020402Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020402s027ltr.pdf | |
| 07/09/2009 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s026ltr.pdf |
| 05/19/2009 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s025ltr.pdf |
| 06/11/2008 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020402s024ltr.pdf |
| 02/08/2006 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s018ltr.pdf |
| 04/28/2006 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s016LTR.pdf |
| 02/26/2004 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20402slr011ltr.pdf |
| 08/02/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20402S5LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-402-s005_Advil.cfm | |
| 04/09/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/06/1997 | 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 |
|---|---|---|---|---|---|
| 02/23/2023 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020402Orig1s055lbl.pdf | |
| 01/25/2022 | SUPPL-53 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020402Orig1s053lbl.pdf | |
| 08/31/2018 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s047lbl.pdf | |
| 08/02/2018 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s046lbl.pdf | |
| 08/08/2017 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402Orig1s043lbl.pdf | |
| 03/08/2017 | SUPPL-42 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402s042lbl.pdf |
| 12/17/2015 | SUPPL-40 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020402Orig1s040lbl.pdf |
| 04/20/2011 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020402Orig1s027lbl.pdf | |
| 03/16/2000 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF |
ADVIL LIQUI-GELS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 020402 | HALEON US HOLDINGS |
| ADVIL MIGRAINE LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 020402 | HALEON US HOLDINGS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 202300 | AMNEAL PHARMS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 206999 | ASCENT PHARMS INC |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 207753 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 078682 | BIONPHARMA |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 206568 | HUMANWELL PURACAP |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 079205 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 077338 | P AND L DEV LLC |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 217236 | PATHEON SOFTGELS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 203599 | SOFGEN PHARMS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 204469 | STRIDES PHARMA |
ADVIL MIGRAINE LIQUI-GELS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 020402 | HALEON US HOLDINGS |
| ADVIL MIGRAINE LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 020402 | HALEON US HOLDINGS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 202300 | AMNEAL PHARMS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 206999 | ASCENT PHARMS INC |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 207753 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 078682 | BIONPHARMA |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 206568 | HUMANWELL PURACAP |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 079205 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 077338 | P AND L DEV LLC |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 217236 | PATHEON SOFTGELS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 203599 | SOFGEN PHARMS |
| IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 204469 | STRIDES PHARMA |