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Generated: October 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022159

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NDA 022159 describes ORAVERSE, which is a drug marketed by Septodont Holding and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ORAVERSE profile page.

The generic ingredient in ORAVERSE is phentolamine mesylate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
Summary for 022159
Tradename:ORAVERSE
Applicant:Septodont Holding
Ingredient:phentolamine mesylate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 022159
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 022159
Suppliers and Packaging for NDA: 022159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159 NDA Septodont, Inc. 0362-0101 0362-0101-10 10 CARTRIDGE in 1 CARTON (0362-0101-10) > 1.7 mL in 1 CARTRIDGE
ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159 NDA Septodont, Inc. 0362-0101 0362-0101-50 50 CARTRIDGE in 1 CARTON (0362-0101-50) > 1.7 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/1.7ML
Approval Date:May 9, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 18, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Sign UpPatent Expiration:May 11, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND TONGUE, AND THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL SUBMUCOSAL INJECTION OF A LOCAL ANESTHETIC
Patent:➤ Sign UpPatent Expiration:May 11, 2021Product Flag?YSubstance Flag?Delist Request?

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