Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022029
Company: HISAMITSU PHARM CO
Company: HISAMITSU PHARM CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | None | Yes | Yes |
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 02/20/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form and 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/2008/022029s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022029s000sumr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/04/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022029Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022029Orig1s019ltr.pdf | |
| 01/31/2019 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022029Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022029Orig1s017ltr.pdf | |
| 01/31/2014 | SUPPL-14 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022029Orig1s014ltr.pdf | |
| 06/13/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2013 | SUPPL-12 | Efficacy-Pediatric |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022029Orig1s012ltr.pdf |
| 11/05/2012 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022029Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022029Orig1s011ltr.pdf | |
| 03/30/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/2011 | SUPPL-9 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022029s009ltr.pdf |
| 09/13/2010 | SUPPL-7 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022029s007ltr.pdf |
| 06/19/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022029s003ltr.pdf | |
| 08/25/2008 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022029s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/04/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022029Orig1s019lbl.pdf | |
| 01/31/2019 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022029Orig1s017lbl.pdf | |
| 01/31/2014 | SUPPL-14 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022029Orig1s014lbl.pdf |
| 11/05/2012 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022029Orig1s011lbl.pdf | |
| 06/19/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022029s003lbl.pdf |
SALONPAS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
PATCH;TOPICAL; 3%;10%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | Yes | 022029 | HISAMITSU PHARM CO |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
PATCH;TOPICAL; 3%;10%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| SALONPAS | MENTHOL; METHYL SALICYLATE | 3%;10% | PATCH;TOPICAL | Over-the-counter | Yes | 022029 | HISAMITSU PHARM CO |