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Details for New Drug Application (NDA): 022466

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NDA 022466 describes ORABLOC, which is a drug marketed by Pierrel and is included in one NDA. It is available from two 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. Ten suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

Summary for NDA: 022466

Tradename:
ORABLOC
Applicant:
Pierrel
Ingredient:
articaine hydrochloride; epinephrine bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 022466

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 Pierrel S.p.A. 45146-110 45146-110-01 100 CARTRIDGE in 1 BOX (45146-110-01) > 1.8 mL in 1 CARTRIDGE
ORABLOC
articaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION 022466 NDA Pierrel S.p.A. 45146-110 45146-110-02 50 CARTRIDGE in 1 BOX (45146-110-02) > 1.8 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)
Approval Date:Feb 26, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)
Approval Date:Feb 26, 2010TE:RLD:Yes


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