Details for New Drug Application (NDA): 022029
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The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the menthol; methyl salicylate profile page.
Summary for 022029
Tradename: | SALONPAS |
Applicant: | Hisamitsu Pharm Co |
Ingredient: | menthol; methyl salicylate |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022029
Generic Entry Date for 022029*:
Constraining patent/regulatory exclusivity:
Dosage:
PATCH;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 022029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029 | NDA | Hisamitsu Pharmaceutical Co., Inc. | 46581-670 | 46581-670-01 | 1 PATCH in 1 POUCH (46581-670-01) |
SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029 | NDA | Hisamitsu Pharmaceutical Co., Inc. | 46581-670 | 46581-670-03 | 3 PATCH in 1 POUCH (46581-670-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | PATCH;TOPICAL | Strength | 3%;10% | ||||
Approval Date: | Feb 20, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 3, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 1, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | PATCH;TOPICAL | Strength | 3%;10% | ||||
Approval Date: | Nov 5, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 3, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
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