Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020589
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | No | No |
| CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/27/1996 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | 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 |
|---|---|---|---|---|---|
| 09/20/2022 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020589Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020589Orig1s039ltr.pdf | |
| 08/30/2018 | SUPPL-37 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf | ||
| 06/21/2017 | SUPPL-35 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020589Orig1s035ltr.pdf | |
| 03/23/2017 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20589Orig1s034ltr.pdf | |
| 07/28/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2012 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/2012 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2013 | SUPPL-29 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020589Orig1s029ltr.pdf | |
| 09/02/2010 | SUPPL-26 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020589s026ltr.pdf |
| 05/19/2009 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020589s024ltr.pdf |
| 06/11/2008 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020589s023ltr.pdf |
| 12/07/2005 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020589s019ltr.pdf |
| 03/18/2005 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20589s017ltr.pdf | |
| 11/14/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf | |
| 09/17/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/2000 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/17/1999 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/14/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2022 | SUPPL-39 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020589Orig1s039lbl.pdf | |
| 08/30/2018 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf | |
| 06/21/2017 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf | |
| 03/23/2017 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf | |
| 12/20/2013 | SUPPL-29 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf |
| 03/18/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf | |
| 08/02/2001 | SUPPL-13 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf |
CHILDREN'S ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
| CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |
CHILDREN'S ADVIL-FLAVORED
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
| CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |