Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022029
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
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
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

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