Details for New Drug Application (NDA): 022466

NDA 022466 describes ORABLOC, which is a drug marketed by Pierrel and is included in one NDA. It is available from four suppliers. Additional details are available on the ORABLOC profile page.

The generic ingredient in ORABLOC is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

Summary for 022466

Tradename:	ORABLOC
Applicant:	Pierrel
Ingredient:	articaine hydrochloride; epinephrine bitartrate
Patents:	0

Pharmacology for NDA: 022466

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 022466

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORABLOC	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022466	NDA AUTHORIZED GENERIC	Burkhart Dental Supply Co., Inc	43498-816	43498-816-01	50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE
ORABLOC	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022466	NDA AUTHORIZED GENERIC	Burkhart Dental Supply Co., Inc	43498-993	43498-993-01	50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)
Approval Date:	Feb 26, 2010	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)
Approval Date:	Feb 26, 2010	TE:		RLD:	Yes

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