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Generated: December 18, 2017

DrugPatentWatch Database Preview

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. It is available from two suppliers. There are four patents 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 forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the benzyl alcohol profile page.

Summary for 022129

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 022129

Medical Subject Heading (MeSH) Categories for 022129

Suppliers and Packaging for NDA: 022129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULESFIA benzyl alcohol LOTION;TOPICAL 022129 NDA Zylera Pharmaceuticals, LLC 23594-780 23594-780-08 1 BOTTLE, PLASTIC in 1 CARTON (23594-780-08) > 227 g in 1 BOTTLE, PLASTIC
ULESFIA benzyl alcohol LOTION;TOPICAL 022129 NDA Zylera Pharmaceuticals, LLC 23594-780 23594-780-88 2 BOTTLE, PLASTIC in 1 CARTON (23594-780-88) > 227 g in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength5%
Approval Date:Apr 9, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:► SubscribePatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:► SubscribePatent Expiration:Jul 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS

Expired Orange Book Patents for NDA: 022129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi IncULESFIAbenzyl alcoholLOTION;TOPICAL022129-001Apr 9, 2009► Subscribe► Subscribe
Shionogi IncULESFIAbenzyl alcoholLOTION;TOPICAL022129-001Apr 9, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Covington
US Department of Justice
Deloitte
US Army
Fish and Richardson
Boehringer Ingelheim
Moodys
Teva
Novartis
Argus Health

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