Details for New Drug Application (NDA): 022129
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The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this compound. Additional details are available on the benzyl alcohol profile page.
Summary for 022129
Tradename: | ULESFIA |
Applicant: | Shionogi Inc |
Ingredient: | benzyl alcohol |
Patents: | 1 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022129
Generic Entry Date for 022129*:
Constraining patent/regulatory exclusivity:
Dosage:
LOTION;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.
Medical Subject Heading (MeSH) Categories for 022129
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 9, 2009 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 19, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TOPICAL TREATMENT OF LICE INFESTATIONS |
Expired US Patents for NDA 022129
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Shionogi Inc | ULESFIA | benzyl alcohol | LOTION;TOPICAL | 022129-001 | Apr 9, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Shionogi Inc | ULESFIA | benzyl alcohol | LOTION;TOPICAL | 022129-001 | Apr 9, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Shionogi Inc | ULESFIA | benzyl alcohol | LOTION;TOPICAL | 022129-001 | Apr 9, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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