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Generated: November 20, 2017

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. Three suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

Summary for 022159

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Therapeutic Class:Cardiovascular Agents
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

Summary 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:► SubscribePatent 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:► SubscribePatent Expiration:May 11, 2021Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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