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

Summary for NDA: 022159

Tradename:
ORAVERSE
Applicant:
Septodont Holding
Ingredient:
phentolamine mesylate
Patents:5
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022159

Mechanism of ActionAdrenergic alpha-Antagonists

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
Patent:6,872,390Patent Expiration:May 11, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,229,630Patent Expiration:Jun 20, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,575,757Patent Expiration:Apr 21, 2025Product Flag?YSubstance Flag?Delist Request?


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