Details for New Drug Application (NDA): 022029
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NDA 022029 describes SALONPAS, which is a drug marketed by Hisamitsu Pharm Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SALONPAS profile page.
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.
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: | ⤷ Get Started Free | Patent Expiration: | Jan 3, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | Patent Expiration: | Jan 3, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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