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. 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. Five 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:	0

Pharmacology for NDA: 022159

Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for 022159

Adrenergic alpha-Antagonists
Antihypertensive Agents

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.4MG/1.7ML
Approval Date:	May 9, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 022159

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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