Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Chubb
Argus Health
Merck
Federal Trade Commission
Covington
US Department of Justice
Teva
Boehringer Ingelheim

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022466

« Back to Dashboard

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 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 N 45146-110-01
ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA Pierrel S.p.A. 45146-110 N 45146-110-02

Profile 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:Yes

Profile 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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Teva
US Department of Justice
Covington
McKinsey
Baxter
Fish and Richardson
Federal Trade Commission
Cipla

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.