Details for New Drug Application (NDA): 022129

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NDA 022129 describes ULESFIA, which is a drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ULESFIA profile page.

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

Medical Subject Heading (MeSH) Categories for 022129

Anesthetics, Local

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DISCN	Dosage:	LOTION;TOPICAL			Strength	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	⤷ Sign Up	Patent Expiration:	May 19, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF LICE INFESTATIONS

Expired US Patents for NDA 022129

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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