Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020812
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INFANT'S ADVIL | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS;ORAL | Over-the-counter | None | Yes | Yes |
| PEDIATRIC ADVIL | IBUPROFEN | 100MG/2.5ML | SUSPENSION/DROPS;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020812_PediatricTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s024ltr.pdf | |
| 03/24/2017 | SUPPL-23 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s023ltr.pdf | |
| 02/26/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2013 | SUPPL-19 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020812Orig1s019ltr.pdf | |
| 04/26/2011 | SUPPL-17 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020812s017ltr.pdf |
| 05/19/2009 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020812s015ltr.pdf |
| 06/11/2008 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020812s014ltr.pdf |
| 04/04/2006 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020812s012ltr.pdf |
| 09/10/2004 | SUPPL-11 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20812s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf |
| 06/28/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/2000 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020812Orig1s007.pdf |
| 02/10/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2000 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf | |
| 05/19/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/06/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf | |
| 03/24/2017 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf | |
| 07/24/2013 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf |
| 01/12/2000 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf |
INFANT'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/DROPS;ORAL; 50MG/1.25ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| INFANT'S ADVIL | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS;ORAL | Over-the-counter | Yes | 020812 | HALEON US HOLDINGS |
PEDIATRIC ADVIL
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.